Product Code: JSC FDA class 1 21 CFR 866.2350

Culture Media, General Nutrient Broth

Microbiology

The Culture Media, General Nutrient Broth is a microbiology diagnostic medium consisting of a non-selective liquid nutrient broth that supports the growth of a wide variety of microorganisms, used in clinical microbiology laboratories for primary culture, enrichment, and subculture of specimens to facilitate organism identification and susceptibility testing. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSC and is regulated under 21 CFR 866.2350, within the Microbiology medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: JSC
Device Class: FDA class 1
Regulation Number: 866.2350
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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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 52 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K850143	SPORDEX CULTURE MEDIA	Mar 05, 1985	Substantially Equivalent	American Sterilizer Co.
K842852	BRAIN HEART INFUSION BROTH	Aug 03, 1984	Substantially Equivalent	Anarobe Systems
K842849	TRYPTICASE SOY BROTH	Aug 03, 1984	Substantially Equivalent	Anarobe Systems
K841221	BRAIN HEART INFUSION BROTH	Apr 04, 1984	Substantially Equivalent	Anaerobe Systems
K841219	SHOPPED MEAT CARBOHYDRATE	Apr 04, 1984	Substantially Equivalent	Anaerobe Systems
K833300	SABOURAUD BHI AGAR	Nov 07, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832620	TRYPTIC SOY BROTH MEDIA	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832619	THIOGLYCOLLATE MEDIUM	Sep 12, 1983	Substantially Equivalent	Carroll Biological Corp.
K832570	EXTRACT BROTH	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K832569	INFUSION BROTH	Sep 12, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K830437	CHS	Mar 17, 1983	Substantially Equivalent	Dms Laboratories
K822665	WILKINS-CHALGREN ANAEROBE BROTH	Sep 21, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822487	MINITEK GRAM-POSITIVE BROTH & SET AND	Sep 21, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K821864	THIOGLYCOLLATE MED. W/VITAMIN K-1	Jul 13, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K821597	BRAIN HEART INFUSION	Jul 08, 1982	Substantially Equivalent	Hardy Media
K821610	THIOGLYCOLATE WITHOUT INDICATOR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821601	TRYPTIC SOY AGAR	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821600	TRYPTIC SOY BROTH	Jul 06, 1982	Substantially Equivalent	Hardy Media
K821598	FLUID THIOGLYCOLLATE BROTH	Jul 06, 1982	Substantially Equivalent	Hardy Media
K820840	CULTURE MEDIA, GENERAL NUTRIENT BROTH	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820796	#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K820795	#4006 TSB-TUBED MEDIA	Apr 08, 1982	Substantially Equivalent	Biomedica, Inc.
K813615	CHL	Feb 04, 1982	Substantially Equivalent	Dms Laboratories
K813611	CHE	Feb 04, 1982	Substantially Equivalent	Dms Laboratories
K812335	TRYPTICASE SOY BROTH BLOOD CULTURE BOTT	Sep 09, 1981	Substantially Equivalent	Fisher Scientific Co., LLC
K811602	TRYPTIC SOY BROTH	Jun 25, 1981	Substantially Equivalent	Micro Media Laboratories
K811323	NUTRIENT BROTH	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811132	EUGON BROTH	May 05, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811056	BRAIN HEART INFUSION	Apr 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K803026	PEPTONE YEAST EXTRACT GLUCOSE BROTH	Dec 22, 1980	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802408	E-VAC BLOOD CULTURE SYSTEM	Oct 23, 1980	Substantially Equivalent	Pfizer Pharmaceuticals
K800429	TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%	Mar 19, 1980	Substantially Equivalent	Abbott Laboratories
K800428	TRYPTIC SOY BROTH W/CYSTEINE AND	Mar 19, 1980	Substantially Equivalent	Abbott Laboratories
K800427	TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT	Mar 19, 1980	Substantially Equivalent	Abbott Laboratories
K800426	TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST	Mar 19, 1980	Substantially Equivalent	Abbott Laboratories
K792056	FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT	Nov 16, 1979	Substantially Equivalent	Fisher Scientific Co., LLC
K791623	TRYPTIC SOY BROTH	Sep 27, 1979	Substantially Equivalent	American Laboratory Supply, Inc.
K791478	FLUID THIOGLYCOLLATE MEDIUM	Sep 04, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791292	BRAIN HEART INFUSION WITH AGAR BROTH	Jul 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791291	BRAIN HEART INFUSION WITH BROTH	Jul 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791194	BRAIN HEART INFUSION BROTH	Jul 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791193	NUTRIENT BROTH	Jul 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791171	TRYPTIC SOY BROTH	Jul 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K790687	BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2	May 03, 1979	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K790625	PEPTONE-YEAST EXTRACT BROTH	May 01, 1979	Substantially Equivalent	Anaerobe Systems
K790620	LOMBARD DOWELL BROTH MEDIUMW/TH REONINE	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790619	LOMBARD-DOWELL BROTH MEDIUM	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790616	ENRICHED THIOGLYCOLLATE MEDIUM	Apr 23, 1979	Substantially Equivalent	Anaerobe Systems
K790615	CHOPPED MEAT MEDIUM	Apr 23, 1979	Substantially Equivalent	Anerobe Systems
K790614	LOMBARD-DOWELL MEDIUM WITH GLUCOSE	Apr 23, 1979	Substantially Equivalent	Anerobe Systems
K790613	CHOPPED MEAT GLOCOSE STARCH MEDIUM	Apr 23, 1979	Substantially Equivalent	Anerobe Systems
K781372	LIQUID T.B.C. MEDIUM	Aug 21, 1978	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.