Product Code: KZI FDA class 1 21 CFR 866.2330

Culture Media, Enriched

Microbiology

The Enriched Culture Media is a laboratory reagent consisting of a nutrient-supplemented growth medium used to support the cultivation of fastidious or slow-growing microorganisms from clinical specimens, facilitating their identification in microbiology diagnostics. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, with no premarket submission required. The product code is KZI, regulated under 21 CFR 866.2330, in the Microbiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

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Basic Information

Product Code: KZI
Device Class: FDA class 1
Regulation Number: 866.2330
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

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 51 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K884208	LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)	Oct 25, 1988	Substantially Equivalent	Oxoid U.S.A., Inc.
K881995	DIAMOND'S MEDIUM MODIFIED	Jun 02, 1988	Substantially Equivalent	Remel Co.
K880134	MIDDLEBROOK 7H11 AGAR	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880131	LOWENSTEIN-JENSEN, GRUFT	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880122	MIDDLEBROOK 7H9 BROTH	Mar 31, 1988	Substantially Equivalent	Hardy Media
K880138	WALLENSTEIN MEDIUM SLANT	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880109	CYSTINE TRYPTIC MEDIUM BASE	Mar 30, 1988	Substantially Equivalent	Hardy Media
K880127	POTATO DEXTROSE AGAR	Mar 07, 1988	Substantially Equivalent	Hardy Media
K874179	BIOTIS (TM) SABHI (DOUBLE POUR)	Jan 28, 1988	Substantially Equivalent	Otisville Biopharm, Inc.
K874177	BIOTIS (TM) BCYE	Dec 04, 1987	Substantially Equivalent	Otisville Biopharm, Inc.
K873267	ECG BASED MEDIA	Nov 04, 1987	Substantially Equivalent	Central Media
K873266	MIDDLEBROOK BASED MEDIA	Oct 28, 1987	Substantially Equivalent	Central Media
K873952	MICRO CULTURE MEDIA P3141, P3136, P3148, P3748	Oct 23, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873321	SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300	Sep 29, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873320	SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD	Sep 29, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873061	TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873060	TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K873058	TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810	Aug 24, 1987	Substantially Equivalent	Lakewood Biochemical Co., Inc.
K872685	IAFP LOWENSTEIN JENSEN SLANT	Aug 11, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872678	IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872671	IAFP T.S.A. W/5% SHEEP BLOOD	Aug 07, 1987	Substantially Equivalent	I.A.F. Production, Inc.
K872193	FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU	Jun 22, 1987	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K870646	MIDDLEBROOK 7H10 AGAR	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870642	COOKED MEAT MEDIUM WITH IRON	Apr 14, 1987	Substantially Equivalent	Hardy Media
K870634	TETRATHIONATE BROTH	Apr 14, 1987	Substantially Equivalent	Hardy Media
K871092	HORSE BLOOD AGAR, ENRICHED	Apr 03, 1987	Substantially Equivalent	bioMerieux, Inc.
K864238	CHOCOLATE AGAR	Mar 31, 1987	Substantially Equivalent	Mds Laboratories, Inc.
K864014	LOMBARD DOWELL AGAR BASE	Oct 29, 1986	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K862761	VACUTAINER BRAND AGAR SLANT	Aug 04, 1986	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K862390	BIOTIS BORDET GENGOU AGAR	Jul 03, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K860410	BIOTIS COOKED MEAT	Feb 24, 1986	Substantially Equivalent	Otisville Biotech, Inc.
K854454	TRYPTIC SOY BLOOD AGAR	Nov 18, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854228	COLUMBIA 5% BLOOD AGAR	Oct 31, 1985	Substantially Equivalent	R. Kent Richards, Inc.
K854064	BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR	Oct 23, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K853236	APL TSA WITH 5% SHEEP BLOOD	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K853233	APL CHOCOLATE AGAR	Aug 19, 1985	Substantially Equivalent	Apl Medical Supplies
K851600	TRYPTIC SOY AGAR W/5% SHEEP BLOOD	May 08, 1985	Substantially Equivalent	Preferred Micro-Media
K851588	CHOCOLATE AGAR	Apr 30, 1985	Substantially Equivalent	Preferred Micro-Media
K850724	CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL	Mar 25, 1985	Substantially Equivalent	Rapid City Regional Hospital, Inc.
K850735	ENRICHED CULTURE MEDIUM	Mar 16, 1985	Substantially Equivalent	Roseville Medical Laboratoriesu
K843065	BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG	Aug 20, 1984	Substantially Equivalent	Otisville Biotech, Inc.
K841749	CHOCOLATE AGAR	May 31, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841748	SHEEP BLOOD AGAR	May 31, 1984	Substantially Equivalent	The Montana Deaconess Medical Center
K841586	CHOCOLATE AGAR	May 31, 1984	Substantially Equivalent	Microline Scientific
K841838	ENRICHED CULTURE MED. TRYPTIC SOY AGAR	May 21, 1984	Substantially Equivalent	Microline Scientific
K841837	ENRICHED CULTURE MED. FLUID THIOGLYC0	May 21, 1984	Substantially Equivalent	Microline Scientific
K832533	SELENITE CYSTINE BROTH	Oct 04, 1983	Substantially Equivalent	Otisville Biotech, Inc.
K830383	FILDES ENRICHMENT SOLUTON	Mar 08, 1983	Substantially Equivalent	Gibco Laboratories Life Technologies, Inc.
K830078	BLOOD AGAR(TSA W/5% SHEEP BLOOD)	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K830074	CHOCOLATE AGAR, ENRICHED	Feb 09, 1983	Substantially Equivalent	bioMerieux, Inc.
K820563	THIOGLYCOLLATE ENRICHED	Mar 16, 1982	Substantially Equivalent	American Laboratory Supply, Inc.