Product Code: JSG FDA class 1 21 CFR 866.2300

Culture Media, Non-Selective And Non-Differential

Microbiology

The Culture Media, Non-Selective and Non-Differential is a microbiology diagnostic medium that supports the growth of a broad range of microorganisms without inhibiting or distinguishing between organism types, used in clinical laboratories as a general growth medium for primary culture and subculture of clinical specimens. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSG and is regulated under 21 CFR 866.2300, within the Microbiology medical specialty.

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510(k)s

209

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JSG
Device Class: FDA class 1
Regulation Number: 866.2300
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 209 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K882495	THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007	Jul 01, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K881564	TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881563	TRYPTOSE PHOSPHATE BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881562	TRYPTOSE BLOOD AGAR BASE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881558	TRYPTOSE AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881557	TRYPTONE	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881554	SKIM MILK DEHYDRATED	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881550	OF BASAL MEDIUM	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881548	MPH AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881546	MALT EXTRACT AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881545	MALT EXTRACT	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881543	LETHEEN AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881542	HEART INFUSION AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881541	GELATIN	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881533	BLOOD AGAR BASE NO. 2	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881532	BLOOD AGAR BASE W/LOW PH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881531	BLOOD AGAR BASE, IMPROVED	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881528	CASEIN PEPTONE, LOW VITAMIN	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881525	COOKED MEAT MEDIUM	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881523	DEXTROSE TRYPTONE BROTH	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K881522	DEXTROSE AGAR	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K880947	NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE	Apr 01, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K880142	TSA W/LEC. & TWEEN. 80	Mar 30, 1988	Substantially Equivalent	Hardy Media
K881115	BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA	Mar 24, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K880114	NUTRIENT BROTH	Mar 08, 1988	Substantially Equivalent	Hardy Media
K875259	BITEK(TM) BLOOD CULTURE SYSTEM	Jan 27, 1988	Substantially Equivalent	Definitive Diagnostics, Inc.
K875273	BITEK(TM) BLOOD CULTURE SYSTEM	Jan 22, 1988	Substantially Equivalent	Definitive Diagnostics, Inc.
K875136	COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750	Jan 12, 1988	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K874538	TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516	Nov 20, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873257	GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA.	Nov 06, 1987	Substantially Equivalent	Central Media
K873483	TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873482	TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873480	TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023	Oct 08, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873328	SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873325	SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873222	BRAIN HEART INFUSION BROTH W/X AND V - #T4540	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873221	BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873220	BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873219	BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873217	BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873243	BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873236	BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873235	BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004	Sep 22, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873232	BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P3302	Sep 18, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873062	TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T9172	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873059	TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873057	TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873053	TRYPTIC SOY AGAR (TSA - PRODUCT #P2802)	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872681	IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872679	IAFP T.S.A. (TRYPTIC SOY AGAR)	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872677	IAFP B.H.I. AGAR	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872668	IAFP T.S.A. W/10% SHEEP BLOOD	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872667	IAFP BRAIN HEART INFUSION BROTH	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K870639	BHI WITH SHEEP BLOOD (5%)	Apr 14, 1987	Substantially Equivalent	Hardy Media
K871098	TRYPTIC SOY AGAR	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K871089	ANAEROBIC BLOOD AGAR (CDC FORMULATION)	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K870800	T2570 THIO W/O IND W/O DEXTROSE	Mar 31, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870799	T2500 FLUID THIO	Mar 31, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870798	T7202 THIO W/O IND W/DEXTROSE	Mar 31, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K864255	TRYPTICASE SOY BROTH	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864254	THIOGLYCOLLATE BROTH	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864240	COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K870595	T4012 TSB 2ML	Mar 30, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870593	T9000 TSB 10ML	Mar 30, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870592	T4013 TSB 5ML	Mar 30, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K870133	HY PBC FLASK	Feb 05, 1987	Substantially Equivalent	Hy Laboratories, Ltd.
K862946	OXOID SIGNAL BLOOD CULTURE SYSTEM	Nov 05, 1986	Substantially Equivalent	Oxoid U.S.A., Inc.
K861480	CHARCOAL AGAR BASE	May 06, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K860411	BIOTIS BHI AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860409	BIOTIS COLUMBIA SHEEP BLOOD AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860408	BIOTIS NUTRIENT AGAR	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860403	BIOTIS TSA WITH 5% RABBIT BLOOD	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860401	BIOTIS TRYPTIC SOY AGAR SLANTS	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860399	BIOTIS TODD HEWITT BROTH	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860397	BIOTIS TSA	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K854455	CDC ANAEROBE BLOOD AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K853690	COLUMBIZ BLOOD AGAR	Sep 17, 1985	Substantially Equivalent	Micro Media Laboratories
K851598	THIOGLYCOLLATE WITHOUT INDICATOR	May 10, 1985	Substantially Equivalent	Preferred Micro-Media
K851601	TRYPTIC SOY BROTH	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851250	SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH	Apr 22, 1985	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K850998	URI-KIT	Apr 01, 1985	Substantially Equivalent	Culture Kits, Inc.
K850848	BRAIN HEART INFUSION AGAR	Mar 20, 1985	Substantially Equivalent	Micro Media Laboratories
K850847	THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN	Mar 20, 1985	Substantially Equivalent	Micro Media Laboratories
K850842	BRAIN HEART INFUSION BROTH	Mar 20, 1985	Substantially Equivalent	Micro Media Laboratories
K850733	MULTIPURPOSE CULTURE MEDIUM	Mar 20, 1985	Substantially Equivalent	Roseville Medical Laboratoriesu
K850658	CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE	Mar 20, 1985	Substantially Equivalent	Oxoid U.S.A., Inc.
K850549	TODD HEWITT BROTH	Mar 11, 1985	Substantially Equivalent	Hardy Media
K850558	CORN MEAL AGAR W/POLYSORBATE 80, CORN MEAL W/POLYS	Mar 07, 1985	Substantially Equivalent	Hardy Media
K844541	TRYPTIC SOY BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844538	COOKED MEAT MEDIUM	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844537	FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844536	THIOGLYCOLLATE W/O INDICATOR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844529	BRAIN HEART INFUSION BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844528	NUTRIENT BROTH	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K844526	THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR	Jan 07, 1985	Substantially Equivalent	bioMerieux, Inc.
K843764	BIOTIS SCHAEDLER AGAR & BROTH	Oct 10, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K841662	MAXIMUM RECOVERY DILUENT	Jun 07, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K842036	BIPHASIC BLOOD CULTURE BOTTLE	Jun 01, 1984	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K841835	MULTIPURPOSE CULTURE MEDIUM	May 14, 1984	Substantially Equivalent	Microline Scientific
K841303	CAMPYLOBACTER THIOGLYCOLLATE MED	Apr 17, 1984	Substantially Equivalent	Anaerobe Systems
K841203	GENERAL NUTRIENT BROTH	Apr 04, 1984	Substantially Equivalent	Smith River Biologicals
K841144	CHOCOLATE AGAR W/COFACTOR	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841143	COLUMBIA AGAR W/5% SHEEP BLOOD	Mar 26, 1984	Substantially Equivalent	Anaerobe Systems
K841130	TRYPTICASE SOY AGAR W/5% SHEEP BLOOD	Mar 23, 1984	Substantially Equivalent	Anaerobe Systems
K840518	SABOURAUD AGAR SLANTS	Mar 02, 1984	Substantially Equivalent	Scientific Device Laboratory, Inc.
K840077	THIOGLYCOLLATE MEDIUM TUBE	Feb 03, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840075	TRYPTICASE SOY BROTH TUBE	Feb 03, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840072	BORDET GENGOU AGAR PLATE	Jan 30, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K840069	ANAEROBIC AGAR PLATE	Jan 30, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834324	TSA	Jan 27, 1984	Substantially Equivalent	Hardy Media
K834427	THIOGEL MEDIUM TUBE	Jan 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834426	LOEFFLER MEDIUM TUBE	Jan 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834425	CTA MEDIUM TUBE	Jan 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834418	CDC ANAEROBE BLOOD AGAR PLATE	Jan 17, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K834323	POTATO DEXTROSE AGAR	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834322	EMMON 3 SABDEX	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834321	THIO W/SUPPLEMENT	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834319	BHI AGAR	Jan 13, 1984	Substantially Equivalent	Hardy Media
K834206	EUGONIC AGAR	Jan 03, 1984	Substantially Equivalent	Acumedia Manufacturers, Inc.
K834006	BRUCELLA MEDIA	Jan 03, 1984	Substantially Equivalent	Micro Media Laboratories
K834016	GN BROTH	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K834014	POTATO DEXTROSE AGAR	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K833507	PREPARED TRYPTIC SOY AGAR 100 MM PLATE	Dec 01, 1983	Substantially Equivalent	Lavco Laboratory, Inc.
K833299	BRUCELLA AGAR MODIFIED	Nov 07, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833296	SABOURAUD DEXTROSE AGAR, EMMONS	Oct 28, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833217	STANDARD METHOD BROTH	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833215	BEEF EXTRACT	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833209	ACIDICASE-BB1	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832534	SHEEP BLOOD AGAR PLATE	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K832611	TRYPTIC SOY AGAR	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K831671	MODIFIED SOYBEAN CASEIN DIGEST BROTH	Jul 28, 1983	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K830805	KNAI SODIUM POTASSIUM ANALYZER	Apr 08, 1983	Substantially Equivalent	Radiometer America, Inc.
K830130	MINIATURE ION SELECTIVE ELECTRODES	Mar 07, 1983	Substantially Equivalent	Ionetics, Inc.
K830077	BRAIN HEART INFUSION AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830075	COLUMBIA SHEEP BLOOD AGAR 5%	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830068	NUTRIENT AGAR	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830063	CONTACT PLATE LECITHIN & POLYSORBATE 80	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K821604	SABOURAUD'S DEXTROSE (SABDEX)	Jul 06, 1982	Substantially Equivalent	Hardy Media
K820791	#4005 TSA SLANT-TUBED MEDIA	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820559	ANAEROBE BLOOD AGAR	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820551	BRUCELLA AGAR W/15% SHEEP BLOOD	Mar 19, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820556	TRYPTIC SOY AGAR	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K820549	THIOGLYCOLLATE W/INDICATOR	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K813232	COOKED MEAT MEDIUM	Dec 03, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K812730	SEPTI-CHEK COLUMBIA BROTH BLOOD CULTURE	Oct 23, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.
K812798	MOTILITY GI MEDIUM	Oct 20, 1981	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K812797	SCHAEDLER AGARS	Oct 20, 1981	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K812795	ANAEROBIC BLOOD AGAR	Oct 20, 1981	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K812732	SEPTI-CHEK BH1 BLOOD CULTURE BOTTLE	Oct 19, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.
K812729	SEPTI-CHEK BLOOD CULTURE BOTTLE ROCHE	Oct 19, 1981	Substantially Equivalent	Hoffmann-La Roche, Inc.
K811735	CTA MEDIUM	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811734	BRUCELLA BROTH	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811731	DEXTROSE BROTH	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811729	COLUMBIA	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811654	BRAIN HEART INFUSION AGAR	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811651	TRYPTICASE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811641	COLUMBIA AGAR BASE	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811640	MEDICASE SOY AGAR	Jul 02, 1981	Substantially Equivalent	Hardy Media
K811612	TRYPTIC SOY AGAR	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811606	FLUID THIOCLYCOLLATE MEDIUM	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811515	THIOGLYCOLLATE MED. W/OUT INDICATOR	Jun 24, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811475	TRYPTIC SOY AGAR W/5% & 10% SHEEP BLOOD	Jun 18, 1981	Substantially Equivalent	Biomedia, Inc.
K811359	AGAR, BACTERIOLOGICAL	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811353	BRAIN HEART INFUSION W/O DEXTROSE	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811340	THIOGLYCOLLATE MEDIUM W/OUT INDICATOR	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811321	STANDARD METHODS AGAR	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811135	COLUMBIA BLOOD AGAR BASE	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811055	BLOOD AGAR BASE PH 7.4	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811047	FLUID THIOGLYCOLLATE MEDIUM	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811052	TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80	May 01, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811051	TRYPTIC SOY AGAR	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811050	TRYPTIC SOY BROTH	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K810553	PEDIATRIC BLOOD CULTURE BOTTLES	Mar 20, 1981	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K803025	CDC ANAEROBE BLOOD AGAR	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K803023	ENRICHED THIOGLYCOLLATE MEDIUM	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802892	CULTURE MEDIA FOR IN VITRO DIAG. USE	Dec 11, 1980	Substantially Equivalent	Radiation Technology, Inc.
K802415	BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT	Oct 31, 1980	Substantially Equivalent	Remel Co.
K802397	ANAEROBE BLOOD AGAR	Oct 23, 1980	Substantially Equivalent	Granite Diagnostics, Inc.
K801980	SPOR-TEST CULTURE MEDIA	Sep 09, 1980	Substantially Equivalent	Mdt Corp., Inc.
K801943	BRAIN HEART INFUSION MICROBIOLOGICAL	Sep 09, 1980	Substantially Equivalent	Radiation Technology, Inc.
K800986	TRYPTICASE SOY AGAR W5% SHEEP BLOOD	Jun 02, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800981	CHOCOLATE AGAR W/ENRICHMENTS	May 28, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K800985	THIOGLYCOLLATE MED. W/O INDICATOR	May 23, 1980	Substantially Equivalent	Quality Assurance Laboratory, Inc.
K792423	TODD HEWITT BROTH	Jan 09, 1980	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792594	TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.	Dec 31, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792543	TRYPTOSE BLOOD AGAR BASE & TRYPTOSE	Dec 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K792276	BRAIN HEART INFUSION W/PABA, O.1%,	Dec 19, 1979	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K791943	NUTRIENT AGAR	Oct 30, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791698	CDC ANAEROBIC SHEEP BLOOD AGAR (BA)	Oct 01, 1979	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K791631	SABOURAUD DEXTROSE AGAR	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791630	BRAIN HEART INFUSION AGAR	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791628	BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD	Sep 27, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791622	COLUMBIA AGAR WITH5% SHEEP	Sep 24, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791620	TRYPTIC SOY AGAR 5% SHEEP BLOOD	Sep 24, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791607	BETA-CELL	Sep 24, 1979	Substantially Equivalent	Biologics Intl., Inc.
K791562	ANAEROBIC BRUCELLA BLOOD AGAR	Sep 17, 1979	Substantially Equivalent	Anaerobe Systems
K791553	CHOCOLATE AGAR	Sep 17, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791544	TRYPTIC SOY AGAR WITH SHEEP BLOOD	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791542	THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791517	COLUMBIA BLOOD AGAR	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791516	TRYPTIC SOY AGAR	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K790622	CHOPPED MEAT AGAR	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790621	CHOPPED MEAT GLUCOSE MEDIUM	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790497	BACTERIOLOGICAL CULTURE MEDIA	Apr 10, 1979	Substantially Equivalent	Micro Media Laboratories
K790459	CEMENT DISPENSER CEMENT MIXER	Mar 28, 1979	Substantially Equivalent	Dow Corning Wright
K790375	TRYPTIC SOY AGAR W/ 5% HORSE BLOOD	Mar 15, 1979	Substantially Equivalent	Granite Diagnostics, Inc.
K781604	CDC ANAEROBE BLOOD AGAR	Oct 10, 1978	Substantially Equivalent	Anaerobe Systems
K760764	YEAST ASSIMILATION AGAR	Oct 29, 1976	Substantially Equivalent	Bioquest
K760459	MUELLER HINTON AGAR W/HEMOGLOBIN	Sep 03, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic