Atlas FDA

JSG

209 FDA 510(k) clearances · Product code

25 daysmedian time to decision
47 days90th percentile
209clearances measured

FDA profile

Official device name
Culture Media, Non-Selective And Non-Differential
Device class
Class I (low risk)
Regulation
21 CFR 866.2300
Medical specialty
Microbiology
Adverse events (MAUDE)
2021: 177 · 2022: 198 · 2023: 182 · 2024: 32 · 2025: 228 · 2026: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (K882495)Lakewood Biochemical Co., Inc.1988-07-01
OF BASAL MEDIUM (K881550)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE AGAR (K881558)Acumedia Manufacturers, Inc.1988-04-18
DEXTROSE TRYPTONE BROTH (K881523)Acumedia Manufacturers, Inc.1988-04-18
BLOOD AGAR BASE W/LOW PH (K881532)Acumedia Manufacturers, Inc.1988-04-18
TRYPTONE (K881557)Acumedia Manufacturers, Inc.1988-04-18
HEART INFUSION AGAR (K881542)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE PHOSPHATE BROTH (K881563)Acumedia Manufacturers, Inc.1988-04-18
DEXTROSE AGAR (K881522)Acumedia Manufacturers, Inc.1988-04-18
MALT EXTRACT (K881545)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT (K881564)Acumedia Manufacturers, Inc.1988-04-18
SKIM MILK DEHYDRATED (K881554)Acumedia Manufacturers, Inc.1988-04-18
COOKED MEAT MEDIUM (K881525)Acumedia Manufacturers, Inc.1988-04-18
TRYPTOSE BLOOD AGAR BASE (K881562)Acumedia Manufacturers, Inc.1988-04-18
MALT EXTRACT AGAR (K881546)Acumedia Manufacturers, Inc.1988-04-18
BLOOD AGAR BASE NO. 2 (K881533)Acumedia Manufacturers, Inc.1988-04-18
LETHEEN AGAR (K881543)Acumedia Manufacturers, Inc.1988-04-18
MPH AGAR (K881548)Acumedia Manufacturers, Inc.1988-04-18
CASEIN PEPTONE, LOW VITAMIN (K881528)Acumedia Manufacturers, Inc.1988-04-18
GELATIN (K881541)Acumedia Manufacturers, Inc.1988-04-18
BLOOD AGAR BASE, IMPROVED (K881531)Acumedia Manufacturers, Inc.1988-04-18
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE (K880947)Lakewood Biochemical Co., Inc.1988-04-01
TSA W/LEC. & TWEEN. 80 (K880142)Hardy Media1988-03-30
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA (K881115)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-03-24
NUTRIENT BROTH (K880114)Hardy Media1988-03-08
BITEK(TM) BLOOD CULTURE SYSTEM (K875259)Definitive Diagnostics, Inc.1988-01-27
BITEK(TM) BLOOD CULTURE SYSTEM (K875273)Definitive Diagnostics, Inc.1988-01-22
COLUMBIA BLOOD AGAR P3308/ COLUMBIA CNA P3750 (K875136)Lakewood Biochemical Co., Inc.1988-01-12
TODD-HEWITT BROTH (0.5ML)#3099 & (5.OML)#T3516 (K874538)Lakewood Biochemical Co., Inc.1987-11-20
GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. (K873257)Central Media1987-11-06
TSA 5% SHEEP BLOOD (SB)/MACCONKEY AGAR #Z3033 (K873482)Lakewood Biochemical Co., Inc.1987-10-08
TSA 5% SHEEP BLOOD/EMB AGAR - PRODUCT #Z3023 (K873480)Lakewood Biochemical Co., Inc.1987-10-08
TSA 5% SHEEP BLOOD (SB)/LEVINE EMB AGAR #Z3020 (K873483)Lakewood Biochemical Co., Inc.1987-10-08
SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE (K873325)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252 (K873328)Lakewood Biochemical Co., Inc.1987-10-02
BRAIN HEART INFUSION AGAR W/5% SB - PRODUCT #P3409 (K873221)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUSION BROTH 10 ML - PRODUCT #T3006 (K873217)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUSION BROTH 0.5 ML - PRODUCT #T3583 (K873219)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUSION BROTH W/X AND V - #T4540 (K873222)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUSION BROTH 4.5 ML - PRODUCT #T3003 (K873220)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD #T3286 (K873243)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR SLANT TUBE, - #T2904 (K873236)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR POUR TUBE, - #T3004 (K873235)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR - BHIA PRODUCT #P3302 (K873232)Lakewood Biochemical Co., Inc.1987-09-18
TRYPTIC SOY AGAR (TSA - PRODUCT #P2802) (K873053)Lakewood Biochemical Co., Inc.1987-08-24
TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8903 7ML (K873057)Lakewood Biochemical Co., Inc.1987-08-24
TRYPTIC SOY AGAR (TSA) SLANT - PRODUCT #T8765 11ML (K873059)Lakewood Biochemical Co., Inc.1987-08-24
TRYPTIC SOY AGAR POUR TUBE - PRODUCT #T9172 (K873062)Lakewood Biochemical Co., Inc.1987-08-24
IAFP C.D.C. ANAEROBIC AGAR W/5% SHEEP BLOOD (K872681)I.A.F. Production, Inc.1987-08-11
IAFP T.S.A. W/10% SHEEP BLOOD (K872668)I.A.F. Production, Inc.1987-08-07
IAFP T.S.A. (TRYPTIC SOY AGAR) (K872679)I.A.F. Production, Inc.1987-08-07
IAFP B.H.I. AGAR (K872677)I.A.F. Production, Inc.1987-08-07
IAFP BRAIN HEART INFUSION BROTH (K872667)I.A.F. Production, Inc.1987-08-07
BHI WITH SHEEP BLOOD (5%) (K870639)Hardy Media1987-04-14
ANAEROBIC BLOOD AGAR (CDC FORMULATION) (K871089)bioMerieux, Inc.1987-04-03
TRYPTIC SOY AGAR (K871098)bioMerieux, Inc.1987-04-03
THIOGLYCOLLATE BROTH (K864254)Mds Laboratories, Inc.1987-03-31
COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD (K864240)Mds Laboratories, Inc.1987-03-31
TRYPTICASE SOY BROTH (K864255)Mds Laboratories, Inc.1987-03-31
T2570 THIO W/O IND W/O DEXTROSE (K870800)Lakewood Biochemical Co., Inc.1987-03-31
T7202 THIO W/O IND W/DEXTROSE (K870798)Lakewood Biochemical Co., Inc.1987-03-31
T2500 FLUID THIO (K870799)Lakewood Biochemical Co., Inc.1987-03-31
T4013 TSB 5ML (K870592)Lakewood Biochemical Co., Inc.1987-03-30
T4012 TSB 2ML (K870595)Lakewood Biochemical Co., Inc.1987-03-30
T9000 TSB 10ML (K870593)Lakewood Biochemical Co., Inc.1987-03-30
HY PBC FLASK (K870133)Hy Laboratories, Ltd.1987-02-05
OXOID SIGNAL BLOOD CULTURE SYSTEM (K862946)Oxoid U.S.A., Inc.1986-11-05
CHARCOAL AGAR BASE (K861480)Gibco Laboratories Life Technologies, Inc.1986-05-06
BIOTIS NUTRIENT AGAR (K860408)Otisville Biotech, Inc.1986-02-24
BIOTIS TODD HEWITT BROTH (K860399)Otisville Biotech, Inc.1986-02-24
BIOTIS TSA (K860397)Otisville Biotech, Inc.1986-02-24
BIOTIS TRYPTIC SOY AGAR SLANTS (K860401)Otisville Biotech, Inc.1986-02-24
BIOTIS BHI AGAR (K860411)Otisville Biotech, Inc.1986-02-24
BIOTIS TSA WITH 5% RABBIT BLOOD (K860403)Otisville Biotech, Inc.1986-02-24
BIOTIS COLUMBIA SHEEP BLOOD AGAR (K860409)Otisville Biotech, Inc.1986-02-24
CDC ANAEROBE BLOOD AGAR (K854455)R. Kent Richards, Inc.1985-11-18
COLUMBIZ BLOOD AGAR (K853690)Micro Media Laboratories1985-09-17
THIOGLYCOLLATE WITHOUT INDICATOR (K851598)Preferred Micro-Media1985-05-10
TRYPTIC SOY BROTH (K851601)Preferred Micro-Media1985-05-08
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH (K851250)Roche Diagnostic Systems, Inc.1985-04-22
URI-KIT (K850998)Culture Kits, Inc.1985-04-01
CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE (K850658)Oxoid U.S.A., Inc.1985-03-20
BRAIN HEART INFUSION AGAR (K850848)Micro Media Laboratories1985-03-20
MULTIPURPOSE CULTURE MEDIUM (K850733)Roseville Medical Laboratoriesu1985-03-20
BRAIN HEART INFUSION BROTH (K850842)Micro Media Laboratories1985-03-20
THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN (K850847)Micro Media Laboratories1985-03-20
TODD HEWITT BROTH (K850549)Hardy Media1985-03-11
CORN MEAL AGAR W/POLYSORBATE 80, CORN MEAL W/POLYS (K850558)Hardy Media1985-03-07
COOKED MEAT MEDIUM (K844538)bioMerieux, Inc.1985-01-07
TRYPTIC SOY BROTH (K844541)bioMerieux, Inc.1985-01-07
NUTRIENT BROTH (K844528)bioMerieux, Inc.1985-01-07
BRAIN HEART INFUSION BROTH (K844529)bioMerieux, Inc.1985-01-07
THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR (K844526)bioMerieux, Inc.1985-01-07
FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR (K844537)bioMerieux, Inc.1985-01-07
THIOGLYCOLLATE W/O INDICATOR (K844536)bioMerieux, Inc.1985-01-07
BIOTIS SCHAEDLER AGAR & BROTH (K843764)Otisville Biotech, Inc.1984-10-10
MAXIMUM RECOVERY DILUENT (K841662)Oxoid U.S.A., Inc.1984-06-07
BIPHASIC BLOOD CULTURE BOTTLE (K842036)Gibco Laboratories Life Technologies, Inc.1984-06-01
MULTIPURPOSE CULTURE MEDIUM (K841835)Microline Scientific1984-05-14
CAMPYLOBACTER THIOGLYCOLLATE MED (K841303)Anaerobe Systems1984-04-17
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