Atlas FDA

LCQ

19 FDA 510(k) clearances · Product code

39 daysmedian time to decision
119 days90th percentile
19clearances measured

FDA profile

Official device name
Fluorescent Immunoassay Gentamicin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3450
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
1998: 2 · 2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (K972609)Bio-Rad1997-08-06
INNOFLUOR GENTAMICIN ASSAY SYSTEM (K955569)Oxis Intl., Inc.1996-02-09
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (K945523)Roche Diagnostic Systems, Inc.1995-03-09
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (K943550)Sigma Diagnostics, Inc.1994-11-17
OPUS GENTAMICIN (K905721)Pb Diagnostic Systems, Inc.1991-02-21
'TDXFLX ANALYZER (K904226)Abbott Laboratories1990-10-29
FPR GENTAMICIN KIT (K894523)Colony Laboratories, Inc.1989-09-28
BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (K852158)Bioprobe Intl., Inc.1985-06-25
GENTAMICIN KIT(FPIA) (K852013)Windsor Laboratories, Inc.1985-06-10
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (K843827)Roche Diagnostic Systems, Inc.1985-02-01
INNOFLOUR GENTAMICIN (K841865)Innotron Diagnostics1984-05-31
IMMPULSE GENTAMICIN ASSAY REAGENTS (K841162)Paragon Diagnostics, Inc.1984-05-02
SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY (K820285)Syva Co.1982-02-18
GENTAMICIN FLUORESCENT IMMUNOASSAY (K813539)American Diagnostic Corp.1981-12-31
AMES TDA GENTAMICIN TEST (K810942)Miles Laboratories, Inc.1981-04-17
DISPOSABLE MEDICATION NEBULIZER (K801867)Hospitax1980-08-20
CYBREX GENTAMICIN (K801084)Abbott Laboratories1980-05-23
FIAX TEST KIT FOR GENTAMICIN QUAN. (K800032)Intl. Diagnostic Technology1980-01-23
GENTAMICIN FLUROIMMUNASSAY KIT (K782025)Technia Diagnostics , Ltd.1979-01-26

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