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KZI — Predicate Candidate Screening

51 FDA 510(k) clearances under this product code; the 50 most recent screened below.

31 daysmedian FDA review time

85 days90th percentile

51clearances measured

K-number	Device	Applicant	Decided	Review days
K884208	LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)	Oxoid U.S.A., Inc.	1988-10-25	19
K881995	DIAMOND'S MEDIUM MODIFIED	Remel Co.	1988-06-02	21
K880122	MIDDLEBROOK 7H9 BROTH	Hardy Media	1988-03-31	85
K880134	MIDDLEBROOK 7H11 AGAR	Hardy Media	1988-03-31	85
K880131	LOWENSTEIN-JENSEN, GRUFT	Hardy Media	1988-03-31	85
K880138	WALLENSTEIN MEDIUM SLANT	Hardy Media	1988-03-30	84
K880109	CYSTINE TRYPTIC MEDIUM BASE	Hardy Media	1988-03-30	84
K880127	POTATO DEXTROSE AGAR	Hardy Media	1988-03-07	61
K874179	BIOTIS (TM) SABHI (DOUBLE POUR)	Otisville Biopharm, Inc.	1988-01-28	107
K874177	BIOTIS (TM) BCYE	Otisville Biopharm, Inc.	1987-12-04	50
K873267	ECG BASED MEDIA	Central Media	1987-11-04	85
K873266	MIDDLEBROOK BASED MEDIA	Central Media	1987-10-28	78
K873952	MICRO CULTURE MEDIA P3141, P3136, P3148, P3748	Lakewood Biochemical Co., Inc.	1987-10-23	25
K873320	SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873321	SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300	Lakewood Biochemical Co., Inc.	1987-09-29	42
K873061	TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405	Lakewood Biochemical Co., Inc.	1987-08-24	20
K873058	TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810	Lakewood Biochemical Co., Inc.	1987-08-24	20
K873060	TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002	Lakewood Biochemical Co., Inc.	1987-08-24	20
K872685	IAFP LOWENSTEIN JENSEN SLANT	I.A.F. Production, Inc.	1987-08-11	35
K872678	IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1	I.A.F. Production, Inc.	1987-08-07	31
K872671	IAFP T.S.A. W/5% SHEEP BLOOD	I.A.F. Production, Inc.	1987-08-07	31
K872193	FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU	Bd Becton Dickinson Vacutainer Systems Preanalytic	1987-06-22	14
K870634	TETRATHIONATE BROTH	Hardy Media	1987-04-14	60
K870646	MIDDLEBROOK 7H10 AGAR	Hardy Media	1987-04-14	60
K870642	COOKED MEAT MEDIUM WITH IRON	Hardy Media	1987-04-14	60
K871092	HORSE BLOOD AGAR, ENRICHED	bioMerieux, Inc.	1987-04-03	16
K864238	CHOCOLATE AGAR	Mds Laboratories, Inc.	1987-03-31	154
K864014	LOMBARD DOWELL AGAR BASE	Gibco Laboratories Life Technologies, Inc.	1986-10-29	14
K862761	VACUTAINER BRAND AGAR SLANT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1986-08-04	13
K862390	BIOTIS BORDET GENGOU AGAR	Otisville Biotech, Inc.	1986-07-03	9
K860410	BIOTIS COOKED MEAT	Otisville Biotech, Inc.	1986-02-24	21
K854454	TRYPTIC SOY BLOOD AGAR	R. Kent Richards, Inc.	1985-11-18	13
K854228	COLUMBIA 5% BLOOD AGAR	R. Kent Richards, Inc.	1985-10-31	13
K854064	BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-10-23	19
K853233	APL CHOCOLATE AGAR	Apl Medical Supplies	1985-08-19	18
K853236	APL TSA WITH 5% SHEEP BLOOD	Apl Medical Supplies	1985-08-19	18
K851600	TRYPTIC SOY AGAR W/5% SHEEP BLOOD	Preferred Micro-Media	1985-05-08	22
K851588	CHOCOLATE AGAR	Preferred Micro-Media	1985-04-30	14
K850724	CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL	Rapid City Regional Hospital, Inc.	1985-03-25	31
K850735	ENRICHED CULTURE MEDIUM	Roseville Medical Laboratoriesu	1985-03-16	24
K843065	BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG	Otisville Biotech, Inc.	1984-08-20	14
K841748	SHEEP BLOOD AGAR	The Montana Deaconess Medical Center	1984-05-31	34
K841749	CHOCOLATE AGAR	The Montana Deaconess Medical Center	1984-05-31	34
K841586	CHOCOLATE AGAR	Microline Scientific	1984-05-31	44
K841838	ENRICHED CULTURE MED. TRYPTIC SOY AGAR	Microline Scientific	1984-05-21	34
K841837	ENRICHED CULTURE MED. FLUID THIOGLYC0	Microline Scientific	1984-05-21	34
K832533	SELENITE CYSTINE BROTH	Otisville Biotech, Inc.	1983-10-04	67
K830383	FILDES ENRICHMENT SOLUTON	Gibco Laboratories Life Technologies, Inc.	1983-03-08	32
K830074	CHOCOLATE AGAR, ENRICHED	bioMerieux, Inc.	1983-02-09	29
K830078	BLOOD AGAR(TSA W/5% SHEEP BLOOD)	bioMerieux, Inc.	1983-02-09	29

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda