Atlas FDA

JSK

70 FDA 510(k) clearances · Product code

35 daysmedian time to decision
57 days90th percentile
70clearances measured

FDA profile

Official device name
Supplement, Culture Media
Device class
Class I (low risk)
Regulation
21 CFR 866.2450
Medical specialty
Microbiology
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RecordFirmDate
ATS NAC-PAC SET (K881949)Alpha-Tec Systems, Inc.1988-05-25
ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (K881879)Alpha-Tec Systems, Inc.1988-05-13
HEMOGLOBIN POWDER (K881566)Acumedia Manufacturers, Inc.1988-04-18
PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (K861997)Hazleton Research Products, Inc.1986-06-10
GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (K861824)Flow Laboratories, Inc.1986-05-20
GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (K861823)Flow Laboratories, Inc.1986-05-20
PENICILLIN-STREPTOMYCIN-FUNGIZONE (K861791)Flow Laboratories, Inc.1986-05-20
KWI (TM) G-CO/TWO (K855172)Micro-Bio-Logics1986-02-20
ABBOTT CATION SUPPLEMENT SOLUTION (K853546)Abbott Laboratories1985-09-06
SUPLEX & SUPLEX DILUENT (K850302)Pro-Lab, Inc.1985-03-22
C.N.V.T. (K850299)Pro-Lab, Inc.1985-03-20
CAMPYLOBACTER SUPPLEMENT-BLASER/WANG (K850307)Pro-Lab, Inc.1985-03-20
MUCOLYSE (K850300)Pro-Lab, Inc.1985-03-20
C.L.A.T. (K850308)Pro-Lab, Inc.1985-03-20
CAMPYLOBACTER SUPPLEMENT -SKIRROW (K850306)Pro-Lab, Inc.1985-03-20
YEAST DIALYSATE (K850301)Pro-Lab, Inc.1985-03-20
SUPPLEMENT FOR CULTURE MEDIUM (K850738)Roseville Medical Laboratoriesu1985-03-20
PRESTON CAMPYLOBACTER SELECTIVE SUPP (K840330)Oxoid U.S.A., Inc.1984-05-11
LEGIONELLA BMPA SELECTIVE SUPPLE (K840333)Oxoid U.S.A., Inc.1984-05-11
LEGIONELLA MWY SELECTIVE SUPPLEMENT (K840331)Oxoid U.S.A., Inc.1984-05-11
CULTROL-ANTIBIOTIC/ANTIMYCOTIC SOLUT (K834115)Bartels Immunodiagnostic Supplies, Inc.1984-03-23
TINSDALE ENRICHMENT (K834066)Remel Co.1984-01-04
LACTOSE (K833210)Acumedia Manufacturers, Inc.1983-10-27
CAMPYLOBACTER SELECTIVE SUPPLE-BLASER (K833019)Gibco Laboratories Life Technologies, Inc.1983-10-14
CAMPYLOBACTER-SELECTIVE SUPPLE-SKIRROW (K833018)Gibco Laboratories Life Technologies, Inc.1983-10-14
CAMPYLOBACTER SELECTIVE SUPPLE-BUTZLER (K833020)Gibco Laboratories Life Technologies, Inc.1983-10-14
MIDDLEBROOK ADC ENRICHMENT (K832902)Gibco Laboratories Life Technologies, Inc.1983-09-26
LEGIONELLA CYE AGAR BASE & BCYE SUPPL (K831469)Oxoid U.S.A., Inc.1983-06-08
CLOSTRIDIUM DIFFICILE SELECTIVE SUPPLE (K831219)Gibco Laboratories Life Technologies, Inc.1983-05-13
GELRITE (K820610)Kelco1982-10-27
YEAST AUTOLYXATE SUPPLEMENT (K822458)Oxoid U.S.A., Inc.1982-09-14
LCAT ANTIBIOTIC SUPPLEMENT (K822460)Oxoid U.S.A., Inc.1982-09-14
VCAT ANTIBIOTIC SUPPLEMENT (K822459)Oxoid U.S.A., Inc.1982-09-14
YERSINIA SELECTIVE SUPPLEMENT (K822511)Gibco Laboratories Life Technologies, Inc.1982-09-14
N-S ANAEROBE SUPPLEMENT (K822461)Oxoid U.S.A., Inc.1982-09-14
G-N ANAEROBE SUPPLEMENT (K822462)Oxoid U.S.A., Inc.1982-09-14
THIOTONE PEPTONE (K811732)Acumedia Manufacturers, Inc.1981-07-02
GELYSATE (K811649)Acumedia Manufacturers, Inc.1981-07-02
BIOSATE (K811730)Acumedia Manufacturers, Inc.1981-07-02
POLYPEPTONE PEPTONE (K811652)Acumedia Manufacturers, Inc.1981-07-02
PHYTONE (K811653)Acumedia Manufacturers, Inc.1981-07-02
VCNT ANTIBIOTIC SUPPLEMENT (K811518)Oxoid U.S.A., Inc.1981-06-24
VCN SUPPLEMENT (K811517)Oxoid U.S.A., Inc.1981-06-24
LEGIONELLA, GROWTH & SELECTIVE, SUPP. (K811516)Oxoid U.S.A., Inc.1981-06-24
HUMAN BLOOD IN ALSEVER'S (K811225)Dutchland Laboratories, Inc.1981-06-12
YEAST EXTRACT (K811360)Acumedia Manufacturers, Inc.1981-05-29
HEMOGLOBIN POWDER (K811357)Acumedia Manufacturers, Inc.1981-05-29
PANCREATIC HYDROLYSATE OF HEART MUSCLE (K811361)Acumedia Manufacturers, Inc.1981-05-29
VITOX (K810932)Oxoid U.S.A., Inc.1981-04-14
PACT SUPPLEMENT (K810591)Bd Becton Dickinson Vacutainer Systems Preanalytic1981-03-20
CAMPYLOBACTER SELECTIVE SUPPLEMENT (BL.) (K802753)Oxoid U.S.A., Inc.1980-12-11
CAMPYLOBACTER SELECTIVE SUPPLEMENT (K800267)Oxoid U.S.A., Inc.1980-03-12
MYCOPLASMA SUPPLEMENT G (K800253)Oxoid U.S.A., Inc.1980-03-12
STREPTOCOCCUS SUPPLEMENT (K800260)Oxoid U.S.A., Inc.1980-03-12
DERMASEL SUPPLEMENT (K800261)Oxoid U.S.A., Inc.1980-03-12
STERILE GC SUPPLEMENT (W/O ANTIBIOTICS) (K800255)Oxoid U.S.A., Inc.1980-03-12
PERFRINGENS SUPPLEMENT A (K800262)Oxoid U.S.A., Inc.1980-03-12
STERILE GC SUPPLEMENT (K800252)Oxoid U.S.A., Inc.1980-03-12
OXYTETRACYCLINE ANTIBIOTIC SUPPLEMENT (K800259)Oxoid U.S.A., Inc.1980-03-12
MYCOPLASMA SUPPLEMENT P (K800254)Oxoid U.S.A., Inc.1980-03-12
CHLORAMPHENICOL ANTIBIOTIC SUPPLEMENT (K800264)Oxoid U.S.A., Inc.1980-03-12
CAMPYLOBACTER GROWTH SUPPLEMENT (K800266)Oxoid U.S.A., Inc.1980-03-12
BORDETELLA SELECTIVE SUPPLEMENT (K800265)Oxoid U.S.A., Inc.1980-03-12
CAMPYLOBACTER SELECTIVE SUPPLEMENT (K800257)Oxoid U.S.A., Inc.1980-03-12
STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT (K800258)Oxoid U.S.A., Inc.1980-03-12
PERFRINGENS SUPPLEMENT B (K800263)Oxoid U.S.A., Inc.1980-03-12
TINSDALE SUPPLEMENT (K800256)Oxoid U.S.A., Inc.1980-03-12
STERILE DEFIBRINATED SHEEP BLOOD (K790801)Central Biological Co.1979-05-03
LYOPHILIZED VIALS OF VCA AND VCAT (K780306)Gibco Laboratories Life Technologies, Inc.1978-03-17
VCA INHIBITOR (K760589)Bd Becton Dickinson Vacutainer Systems Preanalytic1976-10-07

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