Atlas FDA

JSC

52 FDA 510(k) clearances · Product code

25 daysmedian time to decision
47 days90th percentile
52clearances measured

FDA profile

Official device name
Culture Media, General Nutrient Broth
Device class
Class I (low risk)
Regulation
21 CFR 866.2350
Medical specialty
Microbiology
Adverse events (MAUDE)
1998: 2 · 1999: 3 · 2001: 2 · 2002: 2 · 2004: 2 · 2008: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SPORDEX CULTURE MEDIA (K850143)American Sterilizer Co.1985-03-05
BRAIN HEART INFUSION BROTH (K842852)Anarobe Systems1984-08-03
TRYPTICASE SOY BROTH (K842849)Anarobe Systems1984-08-03
BRAIN HEART INFUSION BROTH (K841221)Anaerobe Systems1984-04-04
SHOPPED MEAT CARBOHYDRATE (K841219)Anaerobe Systems1984-04-04
SABOURAUD BHI AGAR (K833300)Acumedia Manufacturers, Inc.1983-11-07
TRYPTIC SOY BROTH MEDIA (K832620)Carroll Biological Corp.1983-09-12
INFUSION BROTH (K832569)Acumedia Manufacturers, Inc.1983-09-12
EXTRACT BROTH (K832570)Acumedia Manufacturers, Inc.1983-09-12
THIOGLYCOLLATE MEDIUM (K832619)Carroll Biological Corp.1983-09-12
CHS (K830437)Dms Laboratories1983-03-17
WILKINS-CHALGREN ANAEROBE BROTH (K822665)Oxoid U.S.A., Inc.1982-09-21
MINITEK GRAM-POSITIVE BROTH & SET AND (K822487)Bd Becton Dickinson Vacutainer Systems Preanalytic1982-09-21
THIOGLYCOLLATE MED. W/VITAMIN K-1 (K821864)Granite Diagnostics, Inc.1982-07-13
BRAIN HEART INFUSION (K821597)Hardy Media1982-07-08
THIOGLYCOLATE WITHOUT INDICATOR (K821610)Hardy Media1982-07-06
FLUID THIOGLYCOLLATE BROTH (K821598)Hardy Media1982-07-06
TRYPTIC SOY AGAR (K821601)Hardy Media1982-07-06
TRYPTIC SOY BROTH (K821600)Hardy Media1982-07-06
CULTURE MEDIA, GENERAL NUTRIENT BROTH (K820840)Blue Ridge Media Co.1982-04-16
#4006 TSB-TUBED MEDIA (K820795)Biomedica, Inc.1982-04-08
#4001 TUBED MEDIA - FLUID THIOGLYCOLLATE (K820796)Biomedica, Inc.1982-04-08
CHE (K813611)Dms Laboratories1982-02-04
CHL (K813615)Dms Laboratories1982-02-04
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT (K812335)Fisher Scientific Co., LLC1981-09-09
TRYPTIC SOY BROTH (K811602)Micro Media Laboratories1981-06-25
NUTRIENT BROTH (K811323)Acumedia Manufacturers, Inc.1981-05-28
EUGON BROTH (K811132)Acumedia Manufacturers, Inc.1981-05-05
BRAIN HEART INFUSION (K811056)Acumedia Manufacturers, Inc.1981-04-29
PEPTONE YEAST EXTRACT GLUCOSE BROTH (K803026)Bd Becton Dickinson Vacutainer Systems Preanalytic1980-12-22
E-VAC BLOOD CULTURE SYSTEM (K802408)Pfizer Pharmaceuticals1980-10-23
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1% (K800429)Abbott Laboratories1980-03-19
TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST (K800426)Abbott Laboratories1980-03-19
TRYPTIC SOY BROTH W/CYSTEINE AND (K800428)Abbott Laboratories1980-03-19
TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT (K800427)Abbott Laboratories1980-03-19
FISHER DIAGNOSTICS ANAEROBIC BLOOD CULT (K792056)Fisher Scientific Co., LLC1979-11-16
TRYPTIC SOY BROTH (K791623)American Laboratory Supply, Inc.1979-09-27
FLUID THIOGLYCOLLATE MEDIUM (K791478)Isle Media and Sterile Products, Inc.1979-09-04
BRAIN HEART INFUSION WITH AGAR BROTH (K791292)Isle Media and Sterile Products, Inc.1979-07-17
BRAIN HEART INFUSION BROTH (K791194)Isle Media and Sterile Products, Inc.1979-07-17
TRYPTIC SOY BROTH (K791171)Isle Media and Sterile Products, Inc.1979-07-17
NUTRIENT BROTH (K791193)Isle Media and Sterile Products, Inc.1979-07-17
BRAIN HEART INFUSION WITH BROTH (K791291)Isle Media and Sterile Products, Inc.1979-07-17
BRUCELLA BROTH W/SPS, 6% SORBITOL & CO2 (K790687)Gibco Laboratories Life Technologies, Inc.1979-05-03
PEPTONE-YEAST EXTRACT BROTH (K790625)Anaerobe Systems1979-05-01
LOMBARD-DOWELL MEDIUM WITH GLUCOSE (K790614)Anerobe Systems1979-04-23
LOMBARD DOWELL BROTH MEDIUMW/TH REONINE (K790620)Anaerobe Systems1979-04-23
ENRICHED THIOGLYCOLLATE MEDIUM (K790616)Anaerobe Systems1979-04-23
CHOPPED MEAT GLOCOSE STARCH MEDIUM (K790613)Anerobe Systems1979-04-23
CHOPPED MEAT MEDIUM (K790615)Anerobe Systems1979-04-23
LOMBARD-DOWELL BROTH MEDIUM (K790619)Anaerobe Systems1979-04-23
LIQUID T.B.C. MEDIUM (K781372)Gibco Laboratories Life Technologies, Inc.1978-08-21

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