Atlas FDA

JSF

87 FDA 510(k) clearances · Product code

35 daysmedian time to decision
84 days90th percentile
87clearances measured

FDA profile

Official device name
Culture Media, Single Biochemical Test
Device class
Class I (low risk)
Regulation
21 CFR 866.2320
Medical specialty
Microbiology
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RecordFirmDate
NUTRIENT GELATIN - PRODUCT NUMBER T2860 (K880946)Lakewood Biochemical Co., Inc.1988-04-01
LAURYL TRYPTOSE BROTH (K880126)Hardy Media1988-03-31
MOELLERS DECARBOXYLASE, LYSINE (K880120)Hardy Media1988-03-31
MOELLERS DECARBOXYLASE, ONITHINE (K880119)Hardy Media1988-03-31
CYSTINE TRYPTIC MEDIUM W/ MALTOSE (K880112)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/LACTOSE (K880113)Hardy Media1988-03-30
MOELLOERS DECARBOXYLASE, ARGININE (K880118)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/DEXTROSE (K880110)Hardy Media1988-03-30
NITRATE BROTH (K880135)Hardy Media1988-03-30
BRILLIANT GREEN BILE BROTH (K880129)Hardy Media1988-03-30
ACETAMIDE AGAR SLANT (K880106)Hardy Media1988-03-30
CYSTINE TRYPTIC MEDIUM W/SUCROSE (K880111)Hardy Media1988-03-30
ONPG TEST REAGENT (K880139)Hardy Media1988-03-30
NUTRIENT GELATIN (K880115)Hardy Media1988-03-08
BIOTIS (TM) MUELLER HINTON W/4% SALT, 6MCG/ML OXAC (K874175)Otisville Biopharm, Inc.1987-12-04
BIOTIS (TM) STARCH HYDROLYSIS WITH BCP (K874174)Otisville Biopharm, Inc.1987-12-04
CULTURE MEDIA T2995/2954/2992/2991/2993/2994/2990 (K873828)Lakewood Biochemical Co., Inc.1987-10-06
IAFP UREA AGAR SLANT (K872691)I.A.F. Production, Inc.1987-08-11
TRYPTONE BROTH, 2% (K870641)Hardy Media1987-04-14
TRYPTONE WATER (1%) (K864256)Mds Laboratories, Inc.1987-03-31
DNASE AGAR (K864241)Mds Laboratories, Inc.1987-03-31
BIOTIS DECARBOXYLASE MEDIA, ARGININE (K862396)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE (K862398)Otisville Biotech, Inc.1986-07-03
BIOTIS DECARBOXYLASE MEDIA, LYSINE (K862397)Otisville Biotech, Inc.1986-07-03
BIOTIS MOTILITY TEST MEDIUM (K862392)Otisville Biotech, Inc.1986-07-03
CAFFEIC ACID DISK (K850194)Remel Co.1985-04-22
ACETATE DIFFERENTIAL AGAR (K850545)Hardy Media1985-03-11
SIMMONS CITRATE AGAR (K850550)Hardy Media1985-03-11
CYSTINE TRYPTIC AGAR W/DEXTROSE (K844542)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/LACTOSE (K844543)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MALTOSE (K844544)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/SUCROSE (K844546)bioMerieux, Inc.1985-01-16
CYSTINE TRYPTIC AGAR W/MANNITOL (K844545)bioMerieux, Inc.1985-01-16
PHENOL RED BROTH W/CARBOHYDRATES (K844539)bioMerieux, Inc.1985-01-07
CYSTINE TRYPTIC AGAR W/FRUCTOSE (K844540)bioMerieux, Inc.1985-01-07
DIFFERENTIATION DISKS BILE ESCULIN (K843364)Difco Laboratories, Inc.1984-09-07
HIPPURATE TEST REAGENT (K842871)Irvine Diagnostic Services1984-08-07
DECARBOXYLASE TEST REAGENT (K842869)Irvine Diagnostic Services1984-08-07
VOGES-PROSKAUER REAGENT A (K842870)Irvine Diagnostic Services1984-08-03
HIPPURATE TEST DISKS (K842868)Irvine Diagnostic Services1984-08-03
INDOLE REAGENT (K842872)Irvine Diagnostic Services1984-08-03
VOGES-PROSKAUER REAGENT B (K842867)Irvine Diagnostic Services1984-08-03
LYSINE IRON AGAR (K842853)Anarobe Systems1984-08-03
CHRISTENSEN'S UREA AGAR (K842855)Anarobe Systems1984-08-03
STREP-A-CHEK (K842600)E-Y Laboratories, Inc.1984-07-11
ZINC DUST SUSPENSION (K842299)Irvine Diagnostic Services1984-06-26
OXIDASE TEST STRIPS-OXIDASESURE (K842298)Irvine Diagnostic Services1984-06-25
SPOT TEST NINHYDRIN REAGENTS (K842290)Difco Laboratories, Inc.1984-06-22
SPOT TEST CATALASE TEST (K842291)Difco Laboratories, Inc.1984-06-22
ONPG DISKS (K842300)Irvine Diagnostic Services1984-06-22
ARGINIE BROTH (K842297)Remel Co.1984-06-22
RIM H2S (K842098)Austin Biological Laboratories1984-06-19
DRIGALSKI LITMUS LACTOSE AGAR (K841659)Oxoid U.S.A., Inc.1984-06-07
RIM SPOT INDOLE (K842097)Austin Biological Laboratories1984-06-07
L-ALANINE-4-NITROANILIDE (K842072)Irvine Diagnostic Services1984-06-07
RIM-DNASE KIT (K841389)Austin Biological Laboratories1984-05-02
PORPHYRIN TEST AGAR (K840685)Remel Co.1984-04-17
SINGLE BIOCHEMICAL TEST (K841212)Smith River Biologicals1984-04-04
CIN AGAR (K834327)Hardy Media1984-01-13
PEM-C (K830397)Health Development Corp.1983-04-12
JORDANS TARTRATE AGAR (K822996)Granite Diagnostics, Inc.1982-11-16
ANDRADES FERMENTATION MEDIA (K822995)Granite Diagnostics, Inc.1982-11-16
PEPTONE IRON AGAR (K823001)Granite Diagnostics, Inc.1982-11-16
MACATE BROTH (K823000)Granite Diagnostics, Inc.1982-11-16
DNASE TEST AGAR W/TOLUIDINE BLUE (K822999)Granite Diagnostics, Inc.1982-11-16
YEAST ASSIMILATION BROTH (K822694)Granite Diagnostics, Inc.1982-09-30
UREA AGAR SLANT (K821594)Hardy Media1982-07-08
EGG YOLK AGAR (PLATE) (K821845)Granite Diagnostics, Inc.1982-07-08
BILE ESCULIN AZIDE BROTH (K821593)Hardy Media1982-07-08
BILE ESCULIN AGAR (K821606)Hardy Media1982-07-06
CULTURE MEDIA, SINGLE BIOCHEM. TEST (K820839)Blue Ridge Media Co.1982-04-16
#2008 SIMMONS CITRATE (K820809)Biomedica, Inc.1982-04-08
PYR BROTH (K820149)Carr-Scarborough Microbiologicals, Inc.1982-02-05
RAPID DECARBOXYLASE/DIHYDROLASE MICROTUB (K812469)Carr Microbiologicals1981-09-14
PHOS MICROTUBES (K812465)Carr Microbiologicals1981-09-14
HIPP MICROTUBE (K812470)Carr Microbiologicals1981-09-14
PYRR MICROTUBE (K812468)Carr Microbiologicals1981-09-14
CEPH LACTAM DISK (K800287)Remel Co.1980-03-19
NITRATE BROTH (K791945)Isle Media and Sterile Products, Inc.1979-10-30
SIMMONS CITRATE AGAR (K791474)Isle Media and Sterile Products, Inc.1979-09-04
.E.C MEDIUM (ESCHERICHIA COLI MEDIUM) (K791476)Isle Media and Sterile Products, Inc.1979-09-04
LOMBARD-DOWELL GLUCOSE AGAR (K790626)Anaerobe Systems1979-04-23
DECARBOXYLASE, BUFFERED LYSINE (K790231)Los Angeles Biological Products1979-02-21
MIC-BIO-PLATE (K781506)Pasco Laboratories, Inc.1978-10-17
MICRODILUTION ANAEROBE ID. PANEL (K781369)Cnr Labs1978-10-03
MIC-2000 (K780907)Gibco Laboratories Life Technologies, Inc.1978-06-22
PRE-REDUCED MEDIA (K780533)Gibco Laboratories Life Technologies, Inc.1978-04-18

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Every clearance here is in the API, with alerts when new ones post.