Atlas FDA

LBZ

27 FDA 510(k) clearances · Product code

48 daysmedian time to decision
104 days90th percentile
27clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Quinidine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3320
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
2007: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (K052826)Seradyn, Inc.2005-12-23
ROCHE ONLINE TDM QUINIDINE (K032332)Roche Diagnostics Corp.2004-01-12
EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 (K011605)Syva Co., Dade Behring, Inc.2001-06-12
QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K964116)Bayer Corp.1996-12-24
QUINIDINE ENZYME IMMUNOASSAY (K964212)Diagnostic Reagents, Inc.1996-12-18
INNOFLUOR QUINIDINE ASSAY SYSTEM (K955568)Oxis Intl., Inc.1996-04-04
COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS (K941440)Roche Diagnostic Systems, Inc.1994-07-06
EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS (K922913)Syva Co.1992-08-24
EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS (K904990)Syva Co.1991-02-04
MODIFIED ACCUFLUOR QUINIDINE REAGENT & CALIBRATOR (K900705)Innotron of Oregon, Inc.1990-04-12
INNOFLUOR(TM) QUINIDINE REAGENT SET (K892208)Innotron of Oregon, Inc.1989-06-09
TDXR FLECAINIDE (K872175)Abbott Laboratories1987-08-13
EASY-TEST QUINIDINE ITEM NO. 67---/95 (K864607)Em Diagnostic Systems, Inc.1987-01-08
EMIT QUINIDINE ASSAY (K862214)Syva Co.1986-06-27
DETERMINATION OF QUINIDINE (K860049)Clinical Data, Inc.1986-01-22
COBAS FP REAGENTS FOR QUINIDINE (K850808)Roche Diagnostic Systems, Inc.1985-03-25
STRATUS QUINIDINE FLUOROMETRIC ENZYME (K843237)American Dade1984-09-12
TDX DISOPYRAMIDE (K842713)Abbott Laboratories1984-08-29
QUINIDINE ANALYTICAL TEST PACK (K840596)E.I. Dupont DE Nemours & Co., Inc.1984-04-04
QUINIDINE FLUORESCENT IMMUNOASSAY (K832493)American Diagnostic Corp.1983-09-12
EMIT CAD QUINIDINE ASSAY FOR USE W/ (K832096)Syva Co.1983-08-08
QUINIDINE REAGENT TEST KIT (K830963)Beckman Instruments, Inc.1983-06-30
EMIT QST QUINIDINE ASSAY (K831355)Syva Co.1983-06-02
TDX QUINIDINE (K822653)Abbott Laboratories1982-09-28
ADVANCE EMIT-CAD QUINIDINE ASSAY (K822588)Syva Co.1982-09-17
AMES TDA QUINIDINE TEST (K812753)Miles Laboratories, Inc.1981-10-19
EMIT-CAD QUINIDINE ASSAY (K811460)Syva Co.1981-06-09

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