Atlas FDA

KLR

17 FDA 510(k) clearances · Product code

55 daysmedian time to decision
113 days90th percentile
17clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Lidocaine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3555
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
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RecordFirmDate
QMS LIDOCAINE (K090282)Thermo Fisher Scientific, Inc.2009-05-29
DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D (K033809)Dade Behring, Inc.2004-02-20
ROCHE ONLINE TDM LIDOCAINE (K032334)Roche Diagnostics Corp.2004-01-12
LIDOCAINE EIA ASSAY (K973102)Diagnostic Reagents, Inc.1997-09-12
EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (K881116)Diagnostic Systems1988-06-20
COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (K853010)Roche Diagnostic Systems, Inc.1985-08-07
STRATUS LIDOCAINE FLUOROMETRIC ENZYME (K843184)American Dade1984-09-26
LIDOCAINE ANALYTICAL TEST PACK ACA (K833379)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
VALPROIC ACID ANALYTICAL TEST PACK (K833381)E.I. Dupont DE Nemours & Co., Inc.1983-12-27
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (K833623)Syva Co.1983-12-08
MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (K832799)Syva Co.1983-10-14
EMIT QST LIDOCAINE ASSAY (K831354)Syva Co.1983-05-27
ADVANCE EMIT CAD DISOPYRAMIDE ASSAY (K823887)Syva Co.1983-01-28
ADVANCE EMIT CAD LIDOCAINE ASSAY (K823866)Syva Co.1983-01-12
LIDOCAINE FLUORESCENT IMMUNOASSAY (K822347)American Diagnostic Corp.1982-08-25
CYBREX LIDOCAINE (K802131)Abbott Laboratories1980-10-31
EMIT DISOPYRAMIDE ASSAY (K801204)Syva Co.1980-06-09

Track KLR automatically

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