Product Code: JSJ FDA class 1 21 CFR 866.2360

Culture Media, Selective And Non-Differential

Microbiology

The Culture Media, Selective and Non-Differential is a microbiology diagnostic medium that contains inhibitory agents to suppress non-target organisms while allowing target organisms to grow without producing distinguishing colony characteristics, used for recovery and enrichment of specific pathogens from clinical specimens without differentiation. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSJ and is regulated under 21 CFR 866.2360, within the Microbiology medical specialty.

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510(k)s

307

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JSJ
Device Class: FDA class 1
Regulation Number: 866.2360
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 307 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K882463	POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421	Jun 22, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K881578	STREPTOSEL	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881574	W-L DIFFERENTIAL MEDIUM	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881573	PHYTONE YEAST EXTRACT AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881571	YM BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881570	SABOURAUD MALTOSE AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881565	INHIBITORY MOLD AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881561	TERGITOL 7 BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881549	MYCOLOGICAL AGAR W/LOW PH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881547	MITIS SALIVARIUS AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881544	LITTMAN AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881530	BRILLIANT GREEN AGAR W/SULFADIAZINE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881526	CHAPMAN STONE MEDIUM	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881524	DERMATOPHYTE TEST MEDIUM	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K880124	LOWENSTEIN-JENSEN, W/NACL	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880123	LOWENSTEIN-JENSEN SLANT	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880945	CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597	Mar 30, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K880141	BCYE, SELECTIVE (W/MPA)	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880140	BCYE AGAR	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880137	BHI WITH C & C SLANT	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880136	CETRIMIDE SELECTIVE AGAR	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880128	SABOURAUD DEXTROSE AGAR W/CHLORO	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880717	SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR	Mar 03, 1988	Substantially Equivalent	Remel Co.
K880716	SLIDE CULTURE PLATE-POTATO FLAKE AGAR	Mar 03, 1988	Substantially Equivalent	Remel Co.
K874176	BIOTIS (TM) HAEMOPHILUS DUCREYI	Feb 05, 1988	Substantially Equivalent	Otisville Biopharm, Inc.
K874178	BIOTIS (TM) BCYE SELECTIVE	Dec 04, 1987	Substantially Equivalent	Otisville Biopharm, Inc.
K874345	TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050	Nov 06, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K874173	BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI	Oct 28, 1987	Substantially Equivalent	Otisville Biopharm, Inc.
K874172	BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR)	Oct 28, 1987	Substantially Equivalent	Otisville Biopharm, Inc.
K873975	PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323	Oct 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873951	MICRO CULTURE MEDIA P3528, P3137, P3149, P3139	Oct 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873827	MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C)	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873479	COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873412	GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038	Oct 06, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873327	SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873326	SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873323	SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873322	SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088	Sep 29, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873319	SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE	Sep 29, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873318	SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL	Sep 29, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873224	BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873216	BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873244	BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873242	BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873241	BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873240	BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T3285	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873239	BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873238	BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873237	BRAIN HEART INFUS AGAR SLANT W/6% SB CHLORAMPHENIC	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873234	BRAIN HEART INFUSION AGAR W/C&C - PRODUCT #P3407	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873233	BRAIN HEART INFUS AGAR W/5% SB & CHLORAMPHENICOL	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873231	BRAIN HEART INFUSION AGAR W/GENTAMICIN - #P3704	Sep 18, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873230	BRAIN HEART INFUSION AGAR IV - PRODUCT #P3591	Sep 18, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873229	BRAIN HEART INFUSION AGAR III - PRODUCT #P3590	Sep 18, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872690	IAFP V. AGAR SELECTIVE	Sep 14, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K873056	TRYPTIC SOY AGAR (TSA) W/SXT - PRODUCT #P2933	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872692	IAFP P.E.A. AGAR W/5% SHEEP BLOOD	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872689	IAFP SABOURAUD DEXTROSE AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872684	IAFP CAMPYLOBACTER BLASER	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872680	IAFP HEKTOEN ENTERIC AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872676	AFP MIDDLEBROOK 7H10 AGAR SLANT	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872674	IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872673	I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872666	IAFP K.V. ANAEROBIC AGAR W/5% SHEEP BLOOD	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872665	IAFP K.V. ANAEROBIC AGAR	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872135	MCBRIDE MEDIUM CM 819	Jun 15, 1987	Substantially Equivalent	Oxoid U.S.A., Inc.
K871786	GBNA MEDIUM	May 21, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871702	MRS AGAR AND MRS BROTH	May 20, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871264	CARIESCREEN LB	May 07, 1987	Substantially Equivalent	Apo Diagnostics, Inc.
K871357	MCBRIDE AGAR, MODIFIED	Apr 14, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870650	NEOMYCIN ANAEROBIC BLOOD AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870647	COLUMBIA CNA AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870645	MIDDLEBROOK 7H11 SELECTIVE AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870637	DERMATOPHYTE TEST MEDIUM	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870635	REGAN-LOWE MEDIUM	Apr 14, 1987	Substantially Equivalent	Hardy Media
K871093	CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K871091	BACTEROIDES BILE ESCULIN AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K871090	ANAEROBIC PEA BLOOD AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K864251	SELENITE F. BROTH	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864250	SABOURAUD DEXTROSE AGAR	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K870342	P3700 COL. CNA W/5% SB	Feb 13, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870134	MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE	Feb 04, 1987	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K864755	PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM	Jan 05, 1987	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K863820	DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300	Oct 08, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K863526	YEP (YEAST EXTRACT PHOSPHATE) AGAR	Sep 19, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863524	REGAN-LOWE CHARCOAL AGAR	Sep 19, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863191	BACTEC 13A MEDIUM (7H13)	Sep 15, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863289	CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN	Sep 03, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K862400	BIOTIS KV LAKED BLOOD AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862399	BIOTIS SXT AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K861734	REGAN-LOWE AGAR	May 16, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K860862	CAMPYLOBACTER CVA AGAR	Mar 18, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K860861	MCBRIDE LISTERIA AGAR	Mar 14, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K860416	BIOTIS REGAN-LOWE	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860407	BIOTIS ANAEROBIC CNA	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860406	BIOTIS MIDDLEBROOK 7H9 BROTH	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860405	BIOTIS TSB WITH 6.5% NACL	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860404	BIOTIS MIDDLEBROOK 7H10 AGAR SLANT	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860398	BIOTIS POTATO DEXTROSE AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860395	BIOTIS HAEMPHILLUS ISOLATION AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860394	BIOTIS CETRIMIDE AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860391	BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860390	BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860383	BIOTIS CLOSTRIDIUM DIFFICILE AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K854457	COLUMBIA CNA AGAR W/5% SHEEP BLOOD	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854456	CAMPYLOBACTER BLOOD AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854453	P.E.Z. AGAR (PHENYLETHANOL AGAR)	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K853335	BLOOD AGAR W/AMPICILLIN, BAP W/AMPICILLIN	Aug 19, 1985	Substantially Equivalent	Hardy Media
K853231	APL SABOURAUD DEXTROSE AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853230	APL MYCOBIOTIC AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853227	APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K852987	CARIESCREEN - SM	Aug 19, 1985	Substantially Equivalent	Pharma-Medica of Scandinavia, Ltd.
K851238	CHAMBER V-9 PLUS AGAR	May 29, 1985	Substantially Equivalent	Bug City Company, Inc.
K851593	SELECTIVE STREPTOCOCCUS AGAR	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851592	SABOURAUD DEXTROSE AGAR	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851591	PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD	May 13, 1985	Substantially Equivalent	Preferred Micro-Media
K851599	TRICHOMONAS BROTH (KUPFORBERG	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851582	GN BROTH	May 02, 1985	Substantially Equivalent	Preferred Micro-Media
K851580	COLUMBIZ CNA AGAR W/5% SHEEP BLOOD	May 02, 1985	Substantially Equivalent	Preferred Micro-Media
K851590	MYCOLOGY AGAR W/ANTIBOTICS	Apr 30, 1985	Substantially Equivalent	Preferred Micro-Media
K850765	STREP-KIT	Apr 24, 1985	Substantially Equivalent	Culture Kits, Inc.
K851249	SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC	Apr 22, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K851348	COBA AGAR	Apr 19, 1985	Substantially Equivalent	Micro Media Laboratories
K851347	KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR	Apr 19, 1985	Substantially Equivalent	Micro Media Laboratories
K850555	CHOCOLATE AGAR W/BACITRACIN, CHOCOLATE W/BACITRACI	Apr 01, 1985	Substantially Equivalent	Hardy Media
K850970	BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA	Mar 29, 1985	Substantially Equivalent	Granite Diagnostics, Inc.
K850969	INHIBITORY MOLD AGAR PLATE	Mar 29, 1985	Substantially Equivalent	Granite Diagnostics, Inc.
K850832	CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASEQ	Mar 29, 1985	Substantially Equivalent	Oxoid U.S.A., Inc.
K850716	SELENITE F BROTH	Mar 22, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850846	SALT BROTH	Mar 20, 1985	Substantially Equivalent	Micro Media Laboratories
K850556	CDC ANEROBIC BLOOD AGAR W/PEA, ANEROBIC PEA	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850554	LKV AGAR, LKV ANAEROBIC AGAR	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850557	SELECTIVE STREP AGAR	Mar 07, 1985	Substantially Equivalent	Hardy Media
K844932	MALT AGAR	Feb 27, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844931	MYCOLOGICAL AGAR W/ANTIBIOTICS	Feb 27, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844929	INHIBITORY MOLD AGAR	Feb 27, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844534	CAMPYLOBACTER CVA AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844533	TRICHOMONAS BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844530	BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844527	SELENITE BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844525	SELENITE CYSTINE BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844524	GN BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844523	CAMPYLOBACTER THIOGLYCOLLATE MEDIUM	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844518	STREPTOCOCCUS SELECTIVE AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844517	COLUMBIA CNA AGAR W/5% SHEEP BLOOD	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K843653	CAMPYLOCACTER SUPPLEMENT	Oct 23, 1984	Substantially Equivalent	Institute Virion , Ltd.
K834424	SFP AGAR PLATES	Oct 23, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834422	PHENYLETHYL ALCOHOL AGAR PLATE	Oct 23, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834419	COLUMBIA CNA AGAR PLATE	Oct 23, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843766	BIOTIS MYCOLOGICAL MEDIA & SLANT	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843765	BIOTIS MYCOBIOTIC AGAR	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K841845	SELECTIVE CULTURE MED. COLUMBIA CNA	May 31, 1984	Substantially Equivalent	Microline Scientific
K841746	SALMONELLA-SHIGELLA AGAR	May 31, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841840	SELECTIVE CULTURE MED. PHENYLETHYL ALCO	May 25, 1984	Substantially Equivalent	Microline Scientific
K841839	SELECTIVE CULTURE MED. SELECTIVE STREP	May 25, 1984	Substantially Equivalent	Microline Scientific
K841673	HAEMOPHILUS ISOLATION AGAR 2827	May 21, 1984	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K841658	KF STREPTOCOCCUS AGAR	May 11, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K840332	CAMPYLOBACTER AGAR BASE	May 11, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K841754	COLUMBIA CNA AGAR	May 07, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841210	SELECTIVE & NON-DIFFERENTIAL	Apr 04, 1984	Substantially Equivalent	Smith River Biologicals
K841140	PHENYLETHYL ALCOHOL BLOOD AGAR	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841139	COLUMBIA AGAR W/COLISTIN, NALADIXIC	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841136	SABOURAUD DEXTROSE AGAR W/CHLORAMPHE	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841135	MYCOSEL AGAR W/CHLORAMPHENICOL &	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841133	THAYER MARTIN MEDIUM	Mar 23, 1984	Substantially Equivalent	Anaerobe Systems
K840890	BUFFERED CYE AGAR DEEP W/SUPPLEMENTS	Mar 23, 1984	Substantially Equivalent	Remel Co.
K840554	BLOOD AGAR W/AMPICILLIN	Feb 27, 1984	Substantially Equivalent	Remel Co.
K840520	MYCOLOGICAL SELECTIVE MEDIUM	Feb 27, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840519	DTM AGAR	Feb 27, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840076	GN BROTH TUBE	Feb 13, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840074	KV BLOOD AGAR PLATE	Feb 13, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840078	SABOURAUD DEXTROSE AGAR TUBE	Jan 30, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K833966	PUMP INFUSION WEARABLE INFUSION PUMP	Jan 25, 1984	Substantially Equivalent	Oximetrix, Inc.
K834417	CAMPY BRUCELLA AGAR PLATE	Jan 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834325	INHIBITORY MOLD AGAR	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834318	BRUCELLA W/H & K	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834317	SELENITE BROTH	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834314	CAMPY 5	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834313	CAMPY 3	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834020	PEPTIC DIGEST AGAR	Jan 13, 1984	Substantially Equivalent	Micro Media Laboratories
K834326	CAMPY 5H	Jan 12, 1984	Substantially Equivalent	Hardy Media
K833967	CVA	Jan 11, 1984	Substantially Equivalent	Remel Co.
K834068	CEB	Jan 03, 1984	Substantially Equivalent	Remel Co.
K834010	DERMATOPHYTE TEST MEDIUM	Jan 03, 1984	Substantially Equivalent	Micro Media Laboratories
K834005	SELECTIVE STREPTOCOCCUS AGAR	Jan 03, 1984	Substantially Equivalent	Micro Media Laboratories
K834008	SABOURAUD DEXTROSE AGAR	Dec 30, 1983	Substantially Equivalent	Micro Media Laboratories
K834018	CAMPY MEDIUM	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834017	CHOCOLATE AGAR W/CHEMICALLY DEFINED	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K833760	CLOSTRIDIUM DIFFICILE EY AGAR P2787	Dec 16, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K833887	BRUCELLA BROTH	Dec 12, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K833886	BRUCELLA AGAR	Dec 12, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K833220	LOWENSTEIN-JENSEN MEDIUM BASE	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833136	CLOSTRIDIUM DIFFICILE	Oct 27, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K833010	CIN AGAR YERSINIA-SELECTIVE AGAR	Oct 27, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K832536	BRILLIANT GREEN AGAR PLATE	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832861	SABOURAUD DEXTROSE AGAR	Sep 26, 1983	Substantially Equivalent	Troy Biologicals, Inc.
K832860	SXT BLOOD AGAR	Sep 26, 1983	Substantially Equivalent	Troy Biologicals, Inc.
K832615	SF BROTH	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832614	SELENITE BROTH	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832613	MANNITOL SALT AGAR	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832588	CIN AGAR	Sep 12, 1983	Substantially Equivalent	Laboratory Products, Inc.
K832583	SABOURAUD DEXTROSE AGAR	Sep 12, 1983	Substantially Equivalent	Acuderm, Inc.
K832582	MYCOSEL AGAR	Sep 12, 1983	Substantially Equivalent	Acuderm, Inc.
K832581	DTM-DERMATOPHYTE TEST MEDIUM	Sep 12, 1983	Substantially Equivalent	Acuderm, Inc.
K831279	CLOSTRIDIUM DIFFICLE MEDIA	May 13, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K831220	CLOSTRIDIUM DIFFICILE MEDIA	May 09, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K823885	SELECTIVE LEGIONELLA MEDIA	Mar 08, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K830384	LEGIONELLA SELECTIVE SUPPLEMENTS	Mar 07, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K830080	BILE ESCULIN AZIDE AGAR	Feb 10, 1983	Substantially Equivalent	bioMerieux, Inc.
K830081	BILE ESCULIN AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830076	CAMPYLOCACTER SELECTIVE AGAR BLASER'S	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830069	MYCOBIOTIC AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830067	PHENYLETHANOL AGAR W/50% SHEEP BLOOD	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830066	SABOURAND DEXTROSE AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K823308	MYCAREL AGAR MYCOBROTIC AGAR	Dec 03, 1982	Substantially Equivalent	Troy Biologicals, Inc.
K823248	SCHAEDLER AGARS	Dec 03, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K823139	SMITH'S MEDIUM	Dec 03, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K823102	AGAR P	Dec 03, 1982	Substantially Equivalent	Dms Laboratories
K823050	CIN AGAR MEDIUM	Nov 16, 1982	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K822994	CORN MEAL AGAR W/POLYSORBATE 80	Nov 16, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822527	ANAEROBE PEA PLATE	Sep 30, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822664	PSEUDOMONAS AGAR BASE, C-N & C-F-C SUPP	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822660	VOGEL JOHNSON AGAR	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822659	YERSINIA AGAR BASE & SUPPLEMENT	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822559	SXT BLOOD AGAR	Sep 14, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821596	6.5% NACL BROTH	Jul 08, 1982	Substantially Equivalent	Hardy Media
K821603	MYCOBIOTIC AGAR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821599	GRAM NEGATIVE BROTH	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821493	LITTMAN OXGAL AGAR	Jun 01, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821218	CAMPY-S AGAR	May 14, 1982	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K820863	MEDIA FOR IN-VITRO DIAGNOSTIC USE	Apr 16, 1982	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K820845	DULTURE MEDIA, SELECTIVE & NON-DIFFER	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820807	#2011 STREP SELECTIVE AGAR	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820806	#2004 PHENYLETHYL ALCHOL AGAR W/SHEEP BL	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820805	#2005 SABOURAUD DEXTROSE AGAR/#4002 SLA	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820804	#2013 CNA 5% SHEEP BLOOD	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820803	#2003 MYCOBIOTIC AGAR	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820799	#2002 MANNITOL SALT AGAR	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820562	CAMPYLOBACTER SELECTIVE MEDIUM	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820561	SABOURAUD DEXTROSE AGAR	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820560	PHENYLETHANOL AGAR W/5% SHEEP BLOOD	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820557	DERMATHPHYTE TEST MEDIUM	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820550	POTATO DEXTROSE AGAR	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820555	ANAEROBE BLOOD AGAR W/KANAMYCIN & VANCO	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820554	COLUMBIZ CNA AGAR W/15% SHEEP BLOOD	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820295	CIN AGAR BASE	Mar 04, 1982	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K820060	CAMPYLOBACTER THIOGLYCOLLATE MED W/5	Jan 28, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K812796	ANAEROBIC CNA BLOOD AGAR	Oct 20, 1981	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K811736	DCLS AGAR	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811733	AZIDE BLOOD AGAR BASE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811650	MACCONKEY BROTH	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811607	COLUMBIA AGAR CNA W/5% SHEEP BLOOD	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811601	PHENYETHYL ALCOHOL AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811356	TRYPTONE AZOLECITHIN TWEEN	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811354	GN BROTH (HAJNA)	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811339	TODD HEWITT BROTH	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811337	TERGITOL 7 AGAR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811336	M-GREEN YEAST & MOLD BROTH	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811333	EC MEDIUM	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811329	SCHAEDLER BROTH	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811328	SCHAEDLER AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811325	SABOURAUD DEXTROSE AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811322	POTATO DEXTROSE AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811137	COLUMBIA CNA AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811128	BRUCELLA AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K810961	CAMPYLOBACTER MED. (PLATE)	May 05, 1981	Substantially Equivalent	Granite Diagnostics, Inc.
K811057	BRILLIANT GREEN BILE BROTH 2%	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K810181	DERMOTOPHYTE TEST MEDIUM	Feb 05, 1981	Substantially Equivalent	Troy Biologicals, Inc.
K802757	BUFFERED CHARCOAL YEAST EXTRACT AGAR	Jan 08, 1981	Substantially Equivalent	Remel Co.
K802758	SELECTIVE CHARCOAL YEAST EXTRACT AGAR	Dec 31, 1980	Substantially Equivalent	Remel Co.
K803027	CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC.	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803024	CDC ANAEROBE LAKED BL AGAR W/PARAMOMY.	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803022	CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC.	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802946	MYCOLOGY CULTURE SYSTEM	Dec 22, 1980	Substantially Equivalent	Orion Diagnostica, Inc.
K802495	CLOSTRIDIUM DIFFICILE AGAR BASE	Dec 18, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K802571	CYE BIPHASIC BLOOD CULTURE MEDIUM	Dec 16, 1980	Substantially Equivalent	Remel Co.
K800754	NICKERSON'S MED. SELECTIVE CULTURE MEDIU	Apr 29, 1980	Substantially Equivalent	Ortho Pharmaceutical Corp.
K800807	CORN MEAL AGAR MEDIA	Apr 24, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K800541	CAMPYLOBACTER AGAR W/5-ANTIMICROBICS	Apr 04, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K792715	SMITH'S SYSTEMIC FUNGAL MEDIUM	Mar 19, 1980	Substantially Equivalent	Meridian Diagnostics, Inc.
K792675	CHARCOAL YEAST EXTRACT(CYE) AGAR	Mar 19, 1980	Substantially Equivalent	Remel Co.
K800329	CAMPYLOBACTER AGAR, CAT. NO. P2536	Mar 03, 1980	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K800158	AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD	Feb 13, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K800156	STAPHYLOCOCCUS MED. 110	Feb 13, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792674	CAMPY BLOOD AGAR	Jan 28, 1980	Substantially Equivalent	Regional Media Laboratories
K792676	CAMPY THIO	Jan 24, 1980	Substantially Equivalent	Remel Co.
K792720	TRYPTIC SOY SXT AGAR W/SHEEP BLOOD	Jan 23, 1980	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K792596	TRYPTIC SOY AGAR W/PHENYLETHANOL &	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792595	SF MEDIUM (SF BROTH, STREPTOCOCCUS	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792593	PHENYLETHANOL AGAR	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792422	TETRATHIONATE BROTH BASE	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792287	KF STREPTOCOCCUS AGAR	Dec 19, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791697	CDC ANAEROBIC BLOOD AGAR PHENETHYLAL	Oct 11, 1979	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K791670	SABOURAUD AGAR MODIFIED	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791629	BRAIN HEART CC AGAR	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791626	MYCOBIOTIC AGAR	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791578	CAMPYLOBACTER SELECTIVE MEDIUM	Sep 27, 1979	Substantially Equivalent	Anaerobe Systems
K791595	BAIRD-PARKER AGAR	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791593	BRILLIANT GREEN AGAR	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791592	BRILLIANT GREEN BILE 2%	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K781603	CDC ANAEROBE BLOOD AGAR W/PHENETHYLALCH.	Oct 10, 1978	Substantially Equivalent	Anaerobe Systems
K781602	CDC ANAEROBE BLOOD W/KANAMYAN/VANCOM.	Oct 10, 1978	Substantially Equivalent	Anaerobe Systems
K771661	MIDDLEBROOK 7H11 AGAR (PLATE)	Sep 12, 1977	Substantially Equivalent	Granite Diagnostics, Inc.
K770004	P.R.A.S. CARY & BLAIR TRANSPORT MEDIUM	Jan 14, 1977	Substantially Equivalent	Scott Laboratories, Inc.
K761359	NEOMYCIN AGAR WITH 5% SHEEP BLOOD	Jan 14, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760460	SCHAEDLER SELECTIVE AGAR-KV	Sep 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760457	SCHAEDLER-SELECTIVE AGAR CNA	Sep 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic