Product Code: JSK FDA class 1 21 CFR 866.2450

Supplement, Culture Media

Microbiology

The Supplement, Culture Media is a microbiology diagnostic additive used to enrich or modify standard culture media by supplying growth factors, nutrients, or selective agents that improve the recovery, viability, or selectivity of the medium for specific microorganisms in clinical diagnostic applications. This device is FDA Class 1, the lowest risk category, requiring only general controls and no premarket notification. It carries product code JSK and is regulated under 21 CFR 866.2450, within the Microbiology medical specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: JSK
Device Class: FDA class 1
Regulation Number: 866.2450
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 70 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K881949	ATS NAC-PAC SET	May 25, 1988	Substantially Equivalent	Alpha-Tec Systems, Inc.
K881879	ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42	May 13, 1988	Substantially Equivalent	Alpha-Tec Systems, Inc.
K881566	HEMOGLOBIN POWDER	Apr 18, 1988	Substantially Equivalent	Acumedia Manufacturers, Inc.
K861997	PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE	Jun 10, 1986	Substantially Equivalent	Hazleton Research Products, Inc.
K861824	GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)	May 20, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K861823	GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN)	May 20, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K861791	PENICILLIN-STREPTOMYCIN-FUNGIZONE	May 20, 1986	Substantially Equivalent	Flow Laboratories, Inc.
K855172	KWI (TM) G-CO/TWO	Feb 20, 1986	Substantially Equivalent	Micro-Bio-Logics
K853546	ABBOTT CATION SUPPLEMENT SOLUTION	Sep 06, 1985	Substantially Equivalent	Abbott Laboratories
K850302	SUPLEX & SUPLEX DILUENT	Mar 22, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850738	SUPPLEMENT FOR CULTURE MEDIUM	Mar 20, 1985	Substantially Equivalent	Roseville Medical Laboratoriesu
K850308	C.L.A.T.	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850307	CAMPYLOBACTER SUPPLEMENT-BLASER/WANG	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850306	CAMPYLOBACTER SUPPLEMENT -SKIRROW	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850301	YEAST DIALYSATE	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850300	MUCOLYSE	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K850299	C.N.V.T.	Mar 20, 1985	Substantially Equivalent	Pro-Lab, Inc.
K840333	LEGIONELLA BMPA SELECTIVE SUPPLE	May 11, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K840331	LEGIONELLA MWY SELECTIVE SUPPLEMENT	May 11, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K840330	PRESTON CAMPYLOBACTER SELECTIVE SUPP	May 11, 1984	Substantially Equivalent	Oxoid U.S.A., Inc.
K834115	CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT	Mar 23, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K834066	TINSDALE ENRICHMENT	Jan 04, 1984	Substantially Equivalent	Remel Co.
K833210	LACTOSE	Oct 27, 1983	Substantially Equivalent	Acumedia Manufacturers, Inc.
K833020	CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER	Oct 14, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K833019	CAMPYLOBACTER SELECTIVE SUPPLE-BLASER	Oct 14, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K833018	CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW	Oct 14, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K832902	MIDDLEBROOK ADC ENRICHMENT	Sep 26, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K831469	LEGIONELLA CYE AGAR BASE & BCYE SUPPL	Jun 08, 1983	Substantially Equivalent	Oxoid U.S.A., Inc.
K831219	CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE	May 13, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K820610	GELRITE	Oct 27, 1982	Substantially Equivalent	Kelco
K822511	YERSINIA SELECTIVE SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K822462	G-N ANAEROBE SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822461	N-S ANAEROBE SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822460	LCAT ANTIBIOTIC SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822459	VCAT ANTIBIOTIC SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K822458	YEAST AUTOLYXATE SUPPLEMENT	Sep 14, 1982	Substantially Equivalent	Oxoid U.S.A., Inc.
K811732	THIOTONE PEPTONE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811730	BIOSATE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811653	PHYTONE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811652	POLYPEPTONE PEPTONE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811649	GELYSATE	Jul 02, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811518	VCNT ANTIBIOTIC SUPPLEMENT	Jun 24, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811517	VCN SUPPLEMENT	Jun 24, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811516	LEGIONELLA, GROWTH & SELECTIVE, SUPP.	Jun 24, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K811225	HUMAN BLOOD IN ALSEVER'S	Jun 12, 1981	Substantially Equivalent	Dutchland Laboratories, Inc.
K811361	PANCREATIC HYDROLYSATE OF HEART MUSCLE	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811360	YEAST EXTRACT	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K811357	HEMOGLOBIN POWDER	May 29, 1981	Substantially Equivalent	Acumedia Manufacturers, Inc.
K810932	VITOX	Apr 14, 1981	Substantially Equivalent	Oxoid U.S.A., Inc.
K810591	PACT SUPPLEMENT	Mar 20, 1981	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K802753	CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.)	Dec 11, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800267	CAMPYLOBACTER SELECTIVE SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800266	CAMPYLOBACTER GROWTH SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800265	BORDETELLA SELECTIVE SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800264	CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800263	PERFRINGENS SUPPLEMENT B	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800262	PERFRINGENS SUPPLEMENT A	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800261	DERMASEL SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800260	STREPTOCOCCUS SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800259	OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800258	STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800257	CAMPYLOBACTER SELECTIVE SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800256	TINSDALE SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800255	STERILE GC SUPPLEMENT (W/O ANTIBIOTICS)	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800254	MYCOPLASMA SUPPLEMENT P	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800253	MYCOPLASMA SUPPLEMENT G	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K800252	STERILE GC SUPPLEMENT	Mar 12, 1980	Substantially Equivalent	Oxoid U.S.A., Inc.
K790801	STERILE DEFIBRINATED SHEEP BLOOD	May 03, 1979	Substantially Equivalent	Central Biological Co.
K780306	LYOPHILIZED VIALS OF VCA AND VCAT	Mar 17, 1978	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K760589	VCA INHIBITOR	Oct 07, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic