Product Code: JSI FDA class 1 21 CFR 866.2360

Culture Media, Selective And Differential

Microbiology

The Culture Media, Selective and Differential is a microbiology diagnostic medium that both inhibits unwanted organisms and produces distinguishing reactions among organisms that do grow, enabling targeted recovery and presumptive identification of specific pathogens from complex clinical specimens in a single step. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSI and is regulated under 21 CFR 866.2360, within the Microbiology medical specialty.

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510(k)s

285

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JSI
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

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 285 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K070691	BBL CHROMAGAR 0157	Nov 20, 2007	Substantially Equivalent	Becton, Dickinson & CO
K974428	DIPSTREAK	Jul 30, 1998	Substantially Equivalent	Novamed , Ltd.
K891593	LISTERIA SELECTIVE ENRICHMENT MEDIUM	Jun 09, 1989	Substantially Equivalent	Oxoid U.S.A., Inc.
K890199	DENTOCULT SM-STRIP MUTANS	Mar 02, 1989	Substantially Equivalent	Orion Corp.
K882182	SALMONELLA-SHIGELLA (SS) AGAR - PRODUCT #P3326	Jun 06, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K881577	MODIFIED SELECTIVE STREPTOCOCCUS AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881576	SELENITE BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881575	SELECTIVE STREPTOCOCCUS AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881572	XL AGAR BASE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881556	TRICHOMONAS BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881555	TINSDALE AGAR BASE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K880125	LOWENSTEIN-JENSEN, SELECTIVE	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880132	DERMATOPHYTE TEST MEDIUM	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880130	ATS MEDIA	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880108	CORN MEAL W/POLYSORBATE 80	Mar 30, 1988	Substantially Equivalent	Hardy Media
K874344	QUAD PLATE (4 DIFFERENT MEDIA)	Nov 06, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873260	CORYNEBACTERIA ISOLATION MEDIA	Nov 06, 1987	Substantially Equivalent	Central Media
K873259	SPECIALTY MEDIA	Nov 06, 1987	Substantially Equivalent	Central Media
K873258	STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA	Nov 06, 1987	Substantially Equivalent	Central Media
K873269	MYCOLOGICAL MEDIA	Nov 04, 1987	Substantially Equivalent	Central Media
K873265	MEDIA FOR ANAEROBIC/MICROAERPHILIC ISOLATION	Oct 28, 1987	Substantially Equivalent	Central Media
K873264	MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS	Oct 28, 1987	Substantially Equivalent	Central Media
K873262	DIFFERENTIAL MEDIA	Oct 28, 1987	Substantially Equivalent	Central Media
K873261	ENTERIC ISOLATION MEDIA	Oct 28, 1987	Substantially Equivalent	Central Media
K873481	HEKTOEN ENTERIC (HE) AGAR/XLD AGAR BIPLATE #Z3016	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873329	HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873228	LEVINE EOSIN METHYLENE BLUE AGAR (LEMB) - #P1507	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873227	MANNITOL SALT AGAR (MSA) PRODUCT #P1706	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873226	XYLOSE LYSINE DEOXYCHOLATE AGAR - PRODUCT #P3601	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873225	EOSIN METHYLENE BLUE AGAR (EMB) - PRODUCT #P1309	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873223	MACCONKEY AGAR - PRODUCT #P1606	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872301	DENTOCULT-SM CULTURE-PADDLE	Sep 11, 1987	Substantially Equivalent	Orion Corp.
K873055	MACCONKEY AGAR - PRODUCT #P1606	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872683	IAFP BILE ESCULIN AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872682	IAFP S.S. AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872675	IAFP MANNITOL NACL	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872672	IAFP BILE ESCULIN AZIDE AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872669	IAFP X.L.D. AGAR	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872956	SORBITOL MACCONKEY AGAR NO. 3 CM 813	Aug 10, 1987	Substantially Equivalent	Oxoid U.S.A., Inc.
K872188	MACCONKEY W/SORBITOL	Jun 24, 1987	Substantially Equivalent	Remel Co.
K872058	ORICULT-N CULTURE-PADDLE	Jun 10, 1987	Substantially Equivalent	Orion Corp.
K870648	STAPHYLOCOCCUS 110 AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870644	BRILLIANT GREEN AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870643	POTATO DEXTROSE AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870640	CETRIMIDE SELECTIVE AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870638	BACTEROIDES BILE ESCULIN AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K871094	BRILLIANT GREEN AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K871088	ANAEROBIC LKV BLOOD AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K864243	MACCONKEY AGAR	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864242	HEKTOEN ENTERIC AGAR	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K870502	CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS	Feb 26, 1987	Substantially Equivalent	Clinical Convenience Products, Inc.
K870341	P1012 BE AGAR	Feb 13, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870340	Z2017, BEA/CNA 5%SB BIPLATE	Feb 13, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870339	P4802 BEA	Feb 13, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870057	T1365 (BIRD SEED AGAR SLANT)	Feb 04, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K864764	CULTURIA MACCONKEY-MUG/CLED SYSTEMS	Dec 29, 1986	Substantially Equivalent	Clinical Convenience Products, Inc.
K864077	CANDIDA BROM CRESOL GREEN AGAR	Oct 31, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863525	DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS	Sep 19, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K863519	CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR	Sep 19, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K854672	CANDI-KIT TM	Jul 11, 1986	Substantially Equivalent	Culture Kits, Inc.
K862394	BIOTIS MITIS SALIVARIUS	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862391	BIOTIS DESOXYCHOLATE AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862389	BIOTIS ACETAMIDE AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862388	BIOTIS TCBS AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K862425	MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM	Jul 02, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K860707	OFPBL	Mar 11, 1986	Substantially Equivalent	Remel Co.
K860402	BIOTIS BISMUTH SULFITE AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860388	BIOTIS KF STREPTOCOCCUS AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860386	BIOTIS SF BROTH	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860385	BIOTIS MAC-MUG	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K855205	MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM	Feb 05, 1986	Substantially Equivalent	Hana Biologics, Inc.
K855110	DRI-FORM UREAPLASMA DIFFERENTIAL BASAL AGAR MED.A8	Jan 07, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K854452	MANNITOL SALT AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854450	BILE ESCULIN AZIDE AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854449	HEKTOEN ENTERIC AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K853691	TERGITOL 7 AGAR	Sep 17, 1985	Substantially Equivalent	Micro Media Laboratories
K853617	APL SIMMONS CITRATE AGAR	Sep 16, 1985	Substantially Equivalent	Apl Medical Supplies
K853611	APL XYLOSE LYSINE DEOXYCHOLATE AGAR	Sep 12, 1985	Substantially Equivalent	Apl Medical Supplies
K853488	STAPH KIT	Aug 28, 1985	Substantially Equivalent	Culture Kits, Inc.
K853235	APL HEKTOEN ENTERIC AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853234	APL MACCONKEY AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853232	APL MANNITOL SALT AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853229	APL 6.5% SODIUM CHLORIDE BROTH	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853228	APL SALMONELLA-SHIGELLA AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853226	APL BIGGY AGAR(NICKERSON)	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853225	APL LEVINE EMB AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K852789	AEROMONAS AGAR(XDCA)	Jul 19, 1985	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K852480	DERM-KIT	Jul 09, 1985	Substantially Equivalent	Culture Kits, Inc.
K851594	SF BROTH	May 14, 1985	Substantially Equivalent	Preferred Micro-Media
K851603	XYLOSE LYSINE DESOXYCHOLATE AGAR	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851578	BILE ESCULIN AGAR	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851577	BILE ESCULIN AZIDE AGAR	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851583	HEKTOEN ENTERIC AGAR	May 02, 1985	Substantially Equivalent	Preferred Micro-Media
K851581	DERMATOPHYTE TEST MEDIUM	May 02, 1985	Substantially Equivalent	Preferred Micro-Media
K851586	MACCONKEY AGAR	Apr 30, 1985	Substantially Equivalent	Preferred Micro-Media
K851585	MANNITOL SALT AGAR	Apr 30, 1985	Substantially Equivalent	Preferred Micro-Media
K851584	LEVINE EMB AGAR	Apr 30, 1985	Substantially Equivalent	Preferred Micro-Media
K850723	SABOURAUD'S DEXTROSE AGAR, BORDET GENGOU AGAR, MYC	Mar 22, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850720	EOSIN METHYLENE BLUE AGAR, SS AGAR, XLD AGAR 6.5%	Mar 22, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850736	SELECTIVE CULTURE MEDIUM	Mar 20, 1985	Substantially Equivalent	Roseville Medical Laboratoriesu
K850565	BIOTIS CHOCOLATE TELLURITE	Mar 13, 1985	Substantially Equivalent	Otisville Biotech, Inc.
K850552	BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE	Mar 11, 1985	Substantially Equivalent	Hardy Media
K844933	BILE ESCULIN AGAR	Feb 27, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844930	BRILLANT GREEN AGAR	Feb 27, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844934	AZIDE AGAR W/5% SHEEP BLOOD	Feb 25, 1985	Substantially Equivalent	American Laboratory Supply, Inc.
K844515	VIOLET RED BILE AGAR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844535	YERSINIA SELECTIVE AGAR	Jan 05, 1985	Substantially Equivalent	bioMerieux, Inc.
K844195	BIOTIS ANAEROBIC KBE AGAR	Nov 27, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834423	S S AGAR PLATE	Oct 23, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834420	MANNITOL-SALT AGAR USP PLATE	Oct 23, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843767	BIOTIS UREA AGAR	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843763	BIOTIS EMB AGAR HOLT-HARRIS	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843762	BIOTIS EMB-LEVINE AGAR	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843761	BIOTIS BIGGY AGAR & BIGGY SLANT	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K843492	NEOMYCIN BLOOD AGAR	Oct 02, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K843194	V AGAR SELECTIVE DEEPS	Sep 14, 1984	Substantially Equivalent	Remel Co.
K843193	STREP SELECTIVE II	Sep 14, 1984	Substantially Equivalent	Remel Co.
K843066	BIOTIS CIN AGAR PLATES	Aug 20, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K842101	COBA AGAR	Jun 07, 1984	Substantially Equivalent	Acumedia Manufacturers, Inc.
K842100	MACCONKEY AGAR, PLUS	Jun 07, 1984	Substantially Equivalent	Acumedia Manufacturers, Inc.
K841753	MACCONKEY AGAR	Jun 07, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841752	XYLOSE-LYSINE DESOXYCHOLATE AGAR	Jun 07, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841747	MANNITOL SALT AGAR	Jun 07, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841844	DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR	May 31, 1984	Substantially Equivalent	Microline Scientific
K841842	DIFFERENTIAL CULTURE MED. MACCONKEY AGAR	May 31, 1984	Substantially Equivalent	Microline Scientific
K841751	LEVINE EOSIN METHYLENE BLUE AGAR	May 31, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841841	DIFFERENTIAL CULTURE MED. MANNITOL SALT	May 25, 1984	Substantially Equivalent	Microline Scientific
K841745	HEKTOEN ENTERIC AGAR	May 11, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841304	HAEMOPHILUS ID QUAD-PLATE	Apr 17, 1984	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K841209	SELECTIVE AND DIFFERENTIAL	Apr 17, 1984	Substantially Equivalent	Smith River Biologicals
K841207	NON-SELECTIVE & NON-DIFFERENTIAL	Apr 17, 1984	Substantially Equivalent	Smith River Biologicals
K840338	HAEMOPHILUS I.D. II TRIPLATE	Apr 17, 1984	Substantially Equivalent	Remel Co.
K841218	CYCLOSERINE-CEFOXITIN FRUCTOSE AGAR	Apr 05, 1984	Substantially Equivalent	Anaerobe Systems
K841142	LEVINE EOSIN METHYLENE BLUE AGAR	Apr 05, 1984	Substantially Equivalent	Anaerobe Systems
K841222	BACTEROIDES BILE ESCULIN GAR	Apr 04, 1984	Substantially Equivalent	Anaerobe Systems
K841141	MACCONKEY AGAR	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841134	MANNITOL SALT AGAR	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841132	EILE-ESCULIN AZIDE AGAR	Mar 23, 1984	Substantially Equivalent	Anaerobe Systems
K841131	XYLOSE LYSINE DESOXYCHOLATE AGAR	Mar 23, 1984	Substantially Equivalent	Anaerobe Systems
K841129	HEKTOEN ENTERIC AGAR	Mar 23, 1984	Substantially Equivalent	Anaerobe Systems
K840889	CLOSTRIDIUM DIFFICILE AGAR DEEP &	Mar 23, 1984	Substantially Equivalent	Remel Co.
K840615	YERSINIA SUPPLEMENT	Mar 09, 1984	Substantially Equivalent	Remel Co.
K840160	B-STREP-TECT-II	Mar 02, 1984	Substantially Equivalent	Uti-Tect, Inc.
K840294	GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD	Feb 17, 1984	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K840190	MACCONKEY AGAR W/TWEEN 80 & AMPICIL	Feb 17, 1984	Substantially Equivalent	Remel Co.
K834320	TCBS	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834019	BIGGY AGAR NICKERSON MEDIUM	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K833508	PREPARED MACCONKEY AGAR	Nov 07, 1983	Substantially Equivalent	Lavco Laboratory, Inc.
K833301	FEELEY-GORMAN AGAR	Oct 28, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833254	STREPTOCOCCUS ID TRIPLATE SYSTEM	Oct 28, 1983	Substantially Equivalent	Granite Diagnostics, Inc.
K833219	STAPHYLOCOCCUS AGAR 10	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833212	MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833205	YERSINIA SELECTIVE AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833204	DEOXYCHOLATE CITRATE AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833203	DEOXYCHOLATE LACTOSE AGAR	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832535	HEKTOEN ENTERIC AGAR PLATE	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832524	BAIRD PARKER AGAR PLATE	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832523	TRYPTOSE SULFITE CYCLOSERINE AGAR PLATE	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832955	BACTEROIDES BILE ESCULIN AGAR	Sep 29, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K832954	V AGAR	Sep 29, 1983	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K832863	STREP ID QUAD	Sep 26, 1983	Substantially Equivalent	Troy Biologicals, Inc.
K832618	BLUE AGAR	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832617	XYLOSE LYSINE DEOXYCHOLATE	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832572	BILE ESCULIN AGAR	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832571	BILE ESCULIN AZIDE AGAR	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832365	TCBS AGAR	Sep 01, 1983	Substantially Equivalent	Granite Diagnostics, Inc.
K830251	CAMPY BLOOD AGAR PLATE	Feb 28, 1983	Substantially Equivalent	Granite Diagnostics, Inc.
K830082	BIGGY AGAR	Feb 10, 1983	Substantially Equivalent	bioMerieux, Inc.
K830065	SALMONELLA-SHIGELLA AGAR	Feb 10, 1983	Substantially Equivalent	bioMerieux, Inc.
K830079	BISMUTH SULFITE AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830072	HEKTOEN ENTERIC AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830071	MACCONKEY AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830070	MANNITOL SALT AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830064	XLD AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K823310	STREPTOCOCCUS SELECTIVE AGAR	Dec 15, 1982	Substantially Equivalent	Troy Biologicals, Inc.
K823307	CAMPYLOBACTER SELECTIVE AGAR	Dec 15, 1982	Substantially Equivalent	Troy Biologicals, Inc.
K823306	HEMOPHILUS QUAD 10 PLATE	Dec 15, 1982	Substantially Equivalent	Troy Biologicals, Inc.
K823122	LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM	Dec 03, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822737	MYCOTRIUM-RS	Dec 03, 1982	Substantially Equivalent	Hana Biologics, Inc.
K822736	MYCOTRIUM-GU	Dec 03, 1982	Substantially Equivalent	Hana Biologics, Inc.
K822997	STREP SELECTIVE AGAR	Nov 17, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K822855	YERSINIA ISOLATION MEDIUM	Nov 05, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821608	CNA/VAGINALIS AGAR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821605	XYLOSE LYSINE DEOXYCHOLATE AGAR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821775	TERGITOL 7 AGAR WITH TTC	Jul 02, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821300	#2010 CAMPHYLOBACTER AGAR	Jun 02, 1982	Substantially Equivalent	Biomedia, Inc.
K821431	XLD AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821427	MANNITOL SALT AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821426	STAPHYLOCOCCUS MEDIUM 1100	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821423	MACCONKEY AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821422	SS AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821421	HEKTOEN ENTERIC AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821420	EMB AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821419	EMB AGAR	Jun 01, 1982	Substantially Equivalent	Interstate Media
K821301	#50002 QUAD DIAGNOSTIC SYSTEM	Jun 01, 1982	Substantially Equivalent	Biomedia, Inc.
K821108	BI PLATE-XLD/HEKTOEN #30012	May 13, 1982	Substantially Equivalent	Biomedia, Inc.
K820844	CULTURE MEDIA, SELECTIVE & DIFFERENTIAL	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820802	#2009 BIGGY AGAR	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820801	#2007 XLD	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820800	#2006 SALMONELLA SHIGELLA AGAR	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820798	#2001 HEKTOEN	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820797	#50001 QUADE DIAGNOSTIC SYSTEM	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820553	BILE ESCULIN AZIDE AGAR	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820552	EOSIN METHYLENE BLUE AGAR	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K812731	SEPTI-CHECK BLOOD CULTURE SLIDE	Oct 19, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.
K812187	SMITH'S SYSTEMIC FUNGAL MEDIUM	Aug 31, 1981	Substantially Equivalent	American Scientific Products
K811648	ENDO AGAR	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811647	SALMONELLA-SHIGELLA AGAR	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811644	HEKTOEN ENTERIC AGAR	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811643	MACCONKEY AGAR	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811642	EOSIN METHYLENE BLUE AGAR (LEVINE)	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811611	MACCONKEY AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811610	EOSIN METHYLENE BLUE AGAR (LEVINE)	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811609	MANNITOL SALT AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811605	HEKTOEN ENTERIC AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811604	XYLOSE LYSINE DEOXYCHOLATE AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811603	SALMONELLA SHIGELLA AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811600	BILE ESCULIN MEDIA	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811599	EOSIN METHYLENE BLUE AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811598	DNASE AGAR MEDIA	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811514	BACILLUS CEREUS SELECTIVE(AGAR&SUPP)	Jun 24, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811478	EMB AGAR, LEVINE	Jun 18, 1981	Substantially Equivalent	Biomedia, Inc.
K811477	MACCONKEY AGAR	Jun 18, 1981	Substantially Equivalent	Biomedia, Inc.
K811474	TRYPTIC SOY AGAR W/5% SHEEP BLOOD & EMB	Jun 18, 1981	Substantially Equivalent	Biomedia, Inc.
K811422	STREP-ID PLATE	Jun 18, 1981	Substantially Equivalent	Carr-Scarborough Microbiologicals, Inc.
K811420	MINERALS MODIFIED MED. BASE & SOD. GLUT.	Jun 16, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811362	TCBS AGAR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811355	LYSINE IRON AGAR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811338	VIOLET RED BILE AGAR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811334	MYCOSEL	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811332	BRAIN HEART CC AGAR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811331	SF BROTH	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811327	SALMONELLA SHIGELLA AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811324	PHENYLETHANOL AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811134	ACU-DESOXYCHOLATE AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811133	EOSIN-METHYLENE BLUE AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811131	HEKTOEN ENTERIC AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811129	LAURYL SULFATE BROTH	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811048	MACCONKEY AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811046	STERILITY TEST BROTH	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811045	LEVIN EOSIN-METHYLENE BLUE AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811043	BISMUTH SULFITE AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811042	XLD AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811041	BRILLIANT GREEN AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811040	CETRIMEDE AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811039	VOGEL & JOHNSON AGAR	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811054	BIGGY AGAR	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811038	BAIRD-PARKER AGAR	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811037	MANNITAL SALT AGAR	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K810933	VOTEL-JOHNSON AGAR (MODIFIED)	Apr 14, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K810931	SS AGAR (MODIFIED)	Apr 14, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K810929	PERFRINGENS AGAR BASE	Apr 14, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K802947	ORICULT DTM	Dec 22, 1980	Substantially Equivalent	Orion Diagnostica, Inc.
K800983	MACCONKEY AGAR	May 23, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800980	HEXTOEN ENTERIC AGAR	May 23, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800745	CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)	May 02, 1980	Substantially Equivalent	Remel Co.
K800157	BISMUTH SULFITE AGAR	Feb 13, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792424	CHOCOLATE TELLURITE AGAR	Dec 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791942	BILE ESCULIN AZIDE AGAR	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791940	UREA AGAR	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791414	DTM (DERMATOPHYTE TEST MEDIUM) AGAR	Oct 17, 1979	Substantially Equivalent	Biomedia, Inc.
K791786	SALMONELLA SHIGELLA AGAR PLATE	Oct 04, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791816	DC AGAR (DESOXYCHOLATE CITRATE AGAR)	Oct 01, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791787	XYLOSE LYSINE DESOXYCHOLATE AGAR PLATE	Oct 01, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791785	MEKTOEN ENTERIC AGAR 100X15MM PLATE	Oct 01, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791627	MANNITOL SALT AGAR	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791621	MANNITOL SALT AGAR	Sep 24, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791579	ANAEROBIC BRUCELLA BLOOD AGAR	Sep 17, 1979	Substantially Equivalent	Anaerobe Systems
K791563	ANAEROBIC BRUCELLA LAKED BLOOD AGAR	Sep 17, 1979	Substantially Equivalent	Anaerobe Systems
K791555	LEVINE EOSIN METHYLER	Sep 17, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791479	ENDO AGAR	Sep 04, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791477	XLD AGAR (XYLASE LYSINE DESOXY AGAR)	Sep 04, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791475	HEKTOEN ENTERIC AGAR	Sep 04, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791520	EMB AGAR (EOSIN METHYLENE BLUE AGAR)	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791519	LEVINE EMB AGAR	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791518	BIGGY AGAR	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791482	MACCONKEY MEDIA	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791480	SS AGAR (SALMONELLA SHIGELLA AGAR)	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791472	PHENYLETHANOL AGAG (PEA)	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K790628	LOMBARD-DOWELL NECMYCIN EGG YOLK AGAR	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790624	LOMBARD-DOWELL BROTH MEDIUM W/LACTATE	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790469	STREP BLOOD AGAR-5% SHEEP BLOOD	Apr 04, 1979	Substantially Equivalent	Biomedia, Inc.
K790119	C/N SCREEN	Mar 08, 1979	Substantially Equivalent	Corning Medical & Scientific
K780704	COLUMBIA AGAR WITH 5% RABBIT BLOOD	May 12, 1978	Substantially Equivalent	Granite Diagnostics, Inc.
K771647	JEMBEC-CVSB PLATE	Oct 19, 1977	Substantially Equivalent	J.P. Kilbourn, Ph.D.