Product Code: JSD FDA class 1 21 CFR 866.2360

Culture Media, Selective Broth

Microbiology

The Culture Media, Selective Broth is a microbiology diagnostic liquid medium that contains inhibitory agents to suppress the growth of unwanted organisms while allowing target organisms to proliferate, used in clinical laboratories to enrich and recover specific pathogens from specimens containing mixed microbial populations. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JSD and is regulated under 21 CFR 866.2360, within the Microbiology medical specialty.

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FEI Numbers

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Basic Information

Product Code: JSD
Device Class: FDA class 1
Regulation Number: 866.2360
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

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 26 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K883075	FASTIDIOUS INOCULUM BROTH	Aug 15, 1988	Substantially Equivalent	Baxter Healthcare Corp
K880107	CAMPY BROTH	Mar 30, 1988	Substantially Equivalent	Hardy Media
K873324	SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331	Oct 02, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873218	BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802	Sep 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K871640	ALKALINE PEPTONE WATER	May 13, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K871447	TODD HEWITT W/CNA (LIM BROTH)	May 13, 1987	Substantially Equivalent	Remel Co.
K870594	T9802 TSB W/6.5% NACL	Mar 30, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K853609	APL TRYPTIC SOY BROTH	Sep 12, 1985	Substantially Equivalent	Apl Medical Supplies
K844547	TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE	Jan 16, 1985	Substantially Equivalent	bioMerieux, Inc.
K841836	SELECTIVE CULTURE MED. TRICHOMONAS	May 14, 1984	Substantially Equivalent	Microline Scientific
K840971	SELECTIVE CULTURE MEDIUM	Apr 13, 1984	Substantially Equivalent	Chatham Biological
K841211	SELECTIVE BROTH	Apr 05, 1984	Substantially Equivalent	Smith River Biologicals
K834013	SF BROTH	Dec 27, 1983	Substantially Equivalent	Micro Media Laboratories
K834015	SELENITE BROTH	Dec 22, 1983	Substantially Equivalent	Micro Media Laboratories
K833759	GROUP STREP BROTH T3472 LIM	Dec 16, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K832310	ROGOSA BROTH	Sep 01, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K822330	BACTEC DILUTING FLUID	Sep 02, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K822131	DERMATOPHYTE TEST MEDIUM	Aug 03, 1982	Substantially Equivalent	Granite Diagnostics, Inc.
K820843	CULTURE MEDIA SELECTIVE BROTH	Apr 16, 1982	Substantially Equivalent	Blue Ridge Media Co.
K820558	SELENITE BROTH	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.
K812451	CAMPY THIOGLYCOLLATE (TUBE)	Sep 23, 1981	Substantially Equivalent	Granite Diagnostics, Inc.
K811326	SABOURAUD LIQUID, BROTH MODIFIED	May 28, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K791589	G N BROTH HAJNA	Sep 17, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791484	SELENITE BROTH	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791481	LAURYL TRYPTOSE BROTH	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.
K791471	SELENITE CYSTINE BROTH	Aug 22, 1979	Substantially Equivalent	Isle Media and Sterile Products, Inc.