Atlas FDA

DJB

19 FDA 510(k) clearances · Product code

43 daysmedian time to decision
191 days90th percentile
19clearances measured

FDA profile

Official device name
Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3450
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
AMES TDA SISOMICIN TEST-CONTROL SERUM (K832792)Miles Laboratories, Inc.1983-09-29
GENTAMICIN TEST PACK-ACA (K831210)E.I. Dupont DE Nemours & Co., Inc.1983-05-25
AMES TDA GENTAMICIN TEST (K821669)Miles Laboratories, Inc.1982-12-15
MRI GENTAMICIN RIA KIT (K812394)Microanalytic Research, Inc.1981-09-08
COAT-A-COUNT GENTAMICIN RIA KIT (K811844)Diagnostic Products Corp.1981-07-10
GAMMA STICK GENTAMICIN RIA KIT (K800537)Alpha Gamma Laboratory1980-04-24
QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770)Bio-Rad1979-10-17
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY (K791547)Bio-Rad1979-10-12
BIOASSAY SYSTEM, MS-2 SERUM (K782049)Abbott Laboratories1979-08-28
AMES TDA/GENTGMICIN (K790584)Miles Laboratories, Inc.1979-06-15
EMIT GENTAMICIN ASSAY (K790829)Syva Co.1979-05-15
RIA KIT, SISOMICIN (K782126)Diagnostic Products Corp.1979-02-15
MACRO-VUE TEST, GENTAMICIN (K781674)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-11-15
GENTAMICIN RIA KIT (K780516)Antibodies, Inc.1978-04-28
AMINOGLYCOSIDE TEST SYSTEM (K772116)Nichols Institute Diagnostics1978-04-28
QUANTITOPE 125-I GENTAMICIN RIA KIT (K780323)Kallestad Laboratories, Inc.1978-03-17
RIANEN GENTAMICIN RIA KIT (K772425)New England Nuclear1978-01-05
AMINOGLYCOSIDE (125I) RIA KIT (K761157)Diagnostic Products Corp.1977-03-01
KIT, RIA, GENTAMICIN SULF. (K760068)New England Nuclear1976-07-20

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