Atlas FDA

KZI

51 FDA 510(k) clearances · Product code

31 daysmedian time to decision
85 days90th percentile
51clearances measured

FDA profile

Official device name
Culture Media, Enriched
Device class
Class I (low risk)
Regulation
21 CFR 866.2330
Medical specialty
Microbiology
Adverse events (MAUDE)
2021: 50 · 2022: 41 · 2023: 23 · 2025: 2,713 · 2026: 303
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (K884208)Oxoid U.S.A., Inc.1988-10-25
DIAMOND'S MEDIUM MODIFIED (K881995)Remel Co.1988-06-02
MIDDLEBROOK 7H9 BROTH (K880122)Hardy Media1988-03-31
MIDDLEBROOK 7H11 AGAR (K880134)Hardy Media1988-03-31
LOWENSTEIN-JENSEN, GRUFT (K880131)Hardy Media1988-03-31
WALLENSTEIN MEDIUM SLANT (K880138)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM BASE (K880109)Hardy Media1988-03-30
POTATO DEXTROSE AGAR (K880127)Hardy Media1988-03-07
BIOTIS (TM) SABHI (DOUBLE POUR) (K874179)Otisville Biopharm, Inc.1988-01-28
BIOTIS (TM) BCYE (K874177)Otisville Biopharm, Inc.1987-12-04
ECG BASED MEDIA (K873267)Central Media1987-11-04
MIDDLEBROOK BASED MEDIA (K873266)Central Media1987-10-28
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748 (K873952)Lakewood Biochemical Co., Inc.1987-10-23
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD (K873320)Lakewood Biochemical Co., Inc.1987-09-29
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 (K873321)Lakewood Biochemical Co., Inc.1987-09-29
TRYPTIC SOY AGAR W/5% SHEEP BLOOD - #T1405 (K873061)Lakewood Biochemical Co., Inc.1987-08-24
TRYPTIC SOY AGAR (TSA) W/5% HORSE BLOOD #P2810 (K873058)Lakewood Biochemical Co., Inc.1987-08-24
TRYPTIC SOY AGAR W/5% SHEEP BLOOD - PRODUCT P1002 (K873060)Lakewood Biochemical Co., Inc.1987-08-24
IAFP LOWENSTEIN JENSEN SLANT (K872685)I.A.F. Production, Inc.1987-08-11
IAFP THIOGLYCOLLATE W/O INDICATOR W/HEMIN&VITA. K1 (K872678)I.A.F. Production, Inc.1987-08-07
IAFP T.S.A. W/5% SHEEP BLOOD (K872671)I.A.F. Production, Inc.1987-08-07
FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU (K872193)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-06-22
TETRATHIONATE BROTH (K870634)Hardy Media1987-04-14
MIDDLEBROOK 7H10 AGAR (K870646)Hardy Media1987-04-14
COOKED MEAT MEDIUM WITH IRON (K870642)Hardy Media1987-04-14
HORSE BLOOD AGAR, ENRICHED (K871092)bioMerieux, Inc.1987-04-03
CHOCOLATE AGAR (K864238)Mds Laboratories, Inc.1987-03-31
LOMBARD DOWELL AGAR BASE (K864014)Gibco Laboratories Life Technologies, Inc.1986-10-29
VACUTAINER BRAND AGAR SLANT (K862761)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-08-04
BIOTIS BORDET GENGOU AGAR (K862390)Otisville Biotech, Inc.1986-07-03
BIOTIS COOKED MEAT (K860410)Otisville Biotech, Inc.1986-02-24
TRYPTIC SOY BLOOD AGAR (K854454)R. Kent Richards, Inc.1985-11-18
COLUMBIA 5% BLOOD AGAR (K854228)R. Kent Richards, Inc.1985-10-31
BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR (K854064)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-10-23
APL CHOCOLATE AGAR (K853233)Apl Medical Supplies1985-08-19
APL TSA WITH 5% SHEEP BLOOD (K853236)Apl Medical Supplies1985-08-19
TRYPTIC SOY AGAR W/5% SHEEP BLOOD (K851600)Preferred Micro-Media1985-05-08
CHOCOLATE AGAR (K851588)Preferred Micro-Media1985-04-30
CULTURE MEDIA NONSELECTIVE & NONDIFFERENTIAL (K850724)Rapid City Regional Hospital, Inc.1985-03-25
ENRICHED CULTURE MEDIUM (K850735)Roseville Medical Laboratoriesu1985-03-16
BIOTIS CDC MODIFIED MCCLUNG-TOABE EGG (K843065)Otisville Biotech, Inc.1984-08-20
SHEEP BLOOD AGAR (K841748)The Montana Deaconess Medical Center1984-05-31
CHOCOLATE AGAR (K841749)The Montana Deaconess Medical Center1984-05-31
CHOCOLATE AGAR (K841586)Microline Scientific1984-05-31
ENRICHED CULTURE MED. TRYPTIC SOY AGAR (K841838)Microline Scientific1984-05-21
ENRICHED CULTURE MED. FLUID THIOGLYC0 (K841837)Microline Scientific1984-05-21
SELENITE CYSTINE BROTH (K832533)Otisville Biotech, Inc.1983-10-04
FILDES ENRICHMENT SOLUTON (K830383)Gibco Laboratories Life Technologies, Inc.1983-03-08
CHOCOLATE AGAR, ENRICHED (K830074)bioMerieux, Inc.1983-02-09
BLOOD AGAR(TSA W/5% SHEEP BLOOD) (K830078)bioMerieux, Inc.1983-02-09
THIOGLYCOLLATE ENRICHED (K820563)American Laboratory Supply, Inc.1982-03-16

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