Atlas FDA

JSJ

307 FDA 510(k) clearances · Product code

27 daysmedian time to decision
60 days90th percentile
307clearances measured

FDA profile

Official device name
Culture Media, Selective And Non-Differential
Device class
Class I (low risk)
Regulation
21 CFR 866.2360
Medical specialty
Microbiology
Adverse events (MAUDE)
2021: 46 · 2022: 56 · 2023: 16 · 2024: 19 · 2025: 337 · 2026: 40
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (K882463)Lakewood Biochemical Co., Inc.1988-06-22
SABOURAUD MALTOSE AGAR (K881570)Acumedia Manufacturers, Inc.1988-04-18
YM BROTH (K881571)Acumedia Manufacturers, Inc.1988-04-18
MYCOLOGICAL AGAR W/LOW PH (K881549)Acumedia Manufacturers, Inc.1988-04-18
CHAPMAN STONE MEDIUM (K881526)Acumedia Manufacturers, Inc.1988-04-18
PHYTONE YEAST EXTRACT AGAR (K881573)Acumedia Manufacturers, Inc.1988-04-18
STREPTOSEL (K881578)Acumedia Manufacturers, Inc.1988-04-18
BRILLIANT GREEN AGAR W/SULFADIAZINE (K881530)Acumedia Manufacturers, Inc.1988-04-18
INHIBITORY MOLD AGAR (K881565)Acumedia Manufacturers, Inc.1988-04-18
MITIS SALIVARIUS AGAR (K881547)Acumedia Manufacturers, Inc.1988-04-18
TERGITOL 7 BROTH (K881561)Acumedia Manufacturers, Inc.1988-04-18
LITTMAN AGAR (K881544)Acumedia Manufacturers, Inc.1988-04-18
W-L DIFFERENTIAL MEDIUM (K881574)Acumedia Manufacturers, Inc.1988-04-18
DERMATOPHYTE TEST MEDIUM (K881524)Acumedia Manufacturers, Inc.1988-04-18
LOWENSTEIN-JENSEN, W/NACL (K880124)Hardy Media1988-03-31
LOWENSTEIN-JENSEN SLANT (K880123)Hardy Media1988-03-31
BHI WITH C & C SLANT (K880137)Hardy Media1988-03-30
BCYE AGAR (K880140)Hardy Media1988-03-30
SABOURAUD DEXTROSE AGAR W/CHLORO (K880128)Hardy Media1988-03-30
CAMPLYOBACTER CULTURE MEDIA PRODUCTS P3873/T3597 (K880945)Lakewood Biochemical Co., Inc.1988-03-30
BCYE, SELECTIVE (W/MPA) (K880141)Hardy Media1988-03-30
CETRIMIDE SELECTIVE AGAR (K880136)Hardy Media1988-03-30
SLIDE CULTURE PLATE-POTATO FLAKE AGAR (K880716)Remel Co.1988-03-03
SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR (K880717)Remel Co.1988-03-03
BIOTIS (TM) HAEMOPHILUS DUCREYI (K874176)Otisville Biopharm, Inc.1988-02-05
BIOTIS (TM) BCYE SELECTIVE (K874178)Otisville Biopharm, Inc.1987-12-04
TSA W/NEOMYCIN & 5% SHEEP BLOOD - # P3104 & Z3050 (K874345)Lakewood Biochemical Co., Inc.1987-11-06
BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI (K874173)Otisville Biopharm, Inc.1987-10-28
BIOTIS (TM) INHIBITORY MOLD AGAR (DOUBLE POUR) (K874172)Otisville Biopharm, Inc.1987-10-28
MICRO CULTURE MEDIA P3528, P3137, P3149, P3139 (K873951)Lakewood Biochemical Co., Inc.1987-10-23
PHENYLETHYL ALCOHOL AGAR(PEA) W/5% SHEEP #P3323 (K873975)Lakewood Biochemical Co., Inc.1987-10-23
COL. CNA 5% SB/MACCONKEY AGAR BIPLATE # Z3206 (K873479)Lakewood Biochemical Co., Inc.1987-10-08
MYCOLOGY W/CYCLOHEXANIDE & CHLORAMPHEMICOL (C&C) (K873827)Lakewood Biochemical Co., Inc.1987-10-08
GRAM NEGATIVE (GN) BROTH, PRODUCT #T3038 (K873412)Lakewood Biochemical Co., Inc.1987-10-06
SABOURAUD DEXTROSE (SD) AGAR SLANT TUBE #T3080 (K873326)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330 (K873327)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412 (K873323)Lakewood Biochemical Co., Inc.1987-10-02
SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL (K873318)Lakewood Biochemical Co., Inc.1987-09-29
SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088 (K873322)Lakewood Biochemical Co., Inc.1987-09-29
SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE (K873319)Lakewood Biochemical Co., Inc.1987-09-29
BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772 (K873224)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUS AGAR SLANT W/10% SHEEP BLOOD C&C (K873216)Lakewood Biochemical Co., Inc.1987-09-23
BRAIN HEART INFUS AGAR W/5% SB PENICILLIN/STREPTOM (K873241)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR W/C&C - PRODUCT #P3407 (K873234)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION SELECTIVE AGAR SLANT - #T4463 (K873239)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUS AGAR SLT W/5% SHEEP BLOOD/GENTAM (K873242)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR SLANT/GENTAMICIN #T4450 (K873238)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUS AGAR W/5% SB & CHLORAMPHENICOL (K873233)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUS AGAR SLANT W/6% SB CHLORAMPHENIC (K873237)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUS AGR SLT W/5% SHP BLD PENIC/STREP (K873244)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR W/ C&C SLANT TUBE #T3285 (K873240)Lakewood Biochemical Co., Inc.1987-09-22
BRAIN HEART INFUSION AGAR W/GENTAMICIN - #P3704 (K873231)Lakewood Biochemical Co., Inc.1987-09-18
BRAIN HEART INFUSION AGAR III - PRODUCT #P3590 (K873229)Lakewood Biochemical Co., Inc.1987-09-18
BRAIN HEART INFUSION AGAR IV - PRODUCT #P3591 (K873230)Lakewood Biochemical Co., Inc.1987-09-18
IAFP V. AGAR SELECTIVE (K872690)I.A.F. Production, Inc.1987-09-14
TRYPTIC SOY AGAR (TSA) W/SXT - PRODUCT #P2933 (K873056)Lakewood Biochemical Co., Inc.1987-08-24
IAFP SABOURAUD DEXTROSE AGAR (K872689)I.A.F. Production, Inc.1987-08-11
IAFP HEKTOEN ENTERIC AGAR (K872680)I.A.F. Production, Inc.1987-08-11
IAFP P.E.A. AGAR W/5% SHEEP BLOOD (K872692)I.A.F. Production, Inc.1987-08-11
AFP MIDDLEBROOK 7H10 AGAR SLANT (K872676)I.A.F. Production, Inc.1987-08-11
IAFP CAMPYLOBACTER BLASER (K872684)I.A.F. Production, Inc.1987-08-11
IAFP COLUMBIA C.N.A. WITH 5% SHEEP BLOOD (K872674)I.A.F. Production, Inc.1987-08-11
I.A.F.P. C.D.C. ANAEROBIC SHEEP BLOOD AGAR W/P.E.A (K872673)I.A.F. Production, Inc.1987-08-11
IAFP K.V. ANAEROBIC AGAR (K872665)I.A.F. Production, Inc.1987-08-07
IAFP K.V. ANAEROBIC AGAR W/5% SHEEP BLOOD (K872666)I.A.F. Production, Inc.1987-08-07
MCBRIDE MEDIUM CM 819 (K872135)Oxoid U.S.A., Inc.1987-06-15
GBNA MEDIUM (K871786)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-21
MRS AGAR AND MRS BROTH (K871702)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-05-20
CARIESCREEN LB (K871264)Apo Diagnostics, Inc.1987-05-07
DERMATOPHYTE TEST MEDIUM (K870637)Hardy Media1987-04-14
REGAN-LOWE MEDIUM (K870635)Hardy Media1987-04-14
MCBRIDE AGAR, MODIFIED (K871357)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-04-14
COLUMBIA CNA AGAR (K870647)Hardy Media1987-04-14
NEOMYCIN ANAEROBIC BLOOD AGAR (K870650)Hardy Media1987-04-14
MIDDLEBROOK 7H11 SELECTIVE AGAR (K870645)Hardy Media1987-04-14
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR) (K871093)bioMerieux, Inc.1987-04-03
ANAEROBIC PEA BLOOD AGAR (K871090)bioMerieux, Inc.1987-04-03
BACTEROIDES BILE ESCULIN AGAR (K871091)bioMerieux, Inc.1987-04-03
SABOURAUD DEXTROSE AGAR (K864250)Mds Laboratories, Inc.1987-03-31
SELENITE F. BROTH (K864251)Mds Laboratories, Inc.1987-03-31
P3700 COL. CNA W/5% SB (K870342)Lakewood Biochemical Co., Inc.1987-02-13
MCBRIDE LISTERIA AGAR W/CYCLOHEXIMIDE, DRI & PRE (K870134)Gibco Laboratories Life Technologies, Inc.1987-02-04
PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM (K864755)Gibco Laboratories Life Technologies, Inc.1987-01-05
DRI-FORM: GBNA LISTERIA MEDIUM NO. M22300 (K863820)Gibco Laboratories Life Technologies, Inc.1986-10-08
YEP (YEAST EXTRACT PHOSPHATE) AGAR (K863526)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
REGAN-LOWE CHARCOAL AGAR (K863524)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-19
BACTEC 13A MEDIUM (7H13) (K863191)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-09-15
CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN (K863289)Gibco Laboratories Life Technologies, Inc.1986-09-03
BIOTIS SXT AGAR (K862399)Otisville Biotech, Inc.1986-07-03
BIOTIS KV LAKED BLOOD AGAR (K862400)Otisville Biotech, Inc.1986-07-03
REGAN-LOWE AGAR (K861734)Gibco Laboratories Life Technologies, Inc.1986-05-16
CAMPYLOBACTER CVA AGAR (K860862)Gibco Laboratories Life Technologies, Inc.1986-03-18
MCBRIDE LISTERIA AGAR (K860861)Gibco Laboratories Life Technologies, Inc.1986-03-14
BIOTIS HAEMPHILLUS ISOLATION AGAR (K860395)Otisville Biotech, Inc.1986-02-24
BIOTIS REGAN-LOWE (K860416)Otisville Biotech, Inc.1986-02-24
BIOTIS MIDDLEBROOK 7H10 AGAR SLANT (K860404)Otisville Biotech, Inc.1986-02-24
BIOTIS MIDDLEBROOK 7H9 BROTH (K860406)Otisville Biotech, Inc.1986-02-24
BIOTIS TSB WITH 6.5% NACL (K860405)Otisville Biotech, Inc.1986-02-24
BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN (K860390)Otisville Biotech, Inc.1986-02-24
BIOTIS CETRIMIDE AGAR (K860394)Otisville Biotech, Inc.1986-02-24
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