Atlas FDA

KLT

56 FDA 510(k) clearances · Product code

56 daysmedian time to decision
213 days90th percentile
56clearances measured

FDA profile

Official device name
Enzyme Immunoassay, Carbamazepine
Device class
Class II (moderate risk)
Regulation
21 CFR 862.3645
Medical specialty
Clinical Toxicology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2005: 3 · 2015: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Carbamazepine Gen 4 (K151578)Roche Diagnostics Operations (Rdo)2015-10-22
ABBOTT CARBAMAZEPINE ASSAY (K123518)Microgenics Corporation2013-06-05
ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS (K103627)Abbott Laboratories2011-10-14
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (K063131)Thermo Electron OY2007-10-05
ADVIA IMS CARBAMAZEPINE METHOD (K042808)Bayer Healthcare, LLC2005-02-08
ONLINE TDM CARBAMAZEPINE (K031902)Roche Diagnostics Corp.2003-09-17
RANDOX CARBAMAZEPINE (K011648)Randox Laboratories, Ltd.2002-01-15
EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (K010814)Syva Co., Dade Behring, Inc.2001-04-13
ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (K000903)Bayer Corp.2000-05-18
IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 (K000007)Diagnostic Products Corp.2000-02-28
SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL (K993987)Syva Co.2000-01-27
ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 (K993028)Syva Co.2000-01-27
VITROS CHEMISTRY PRODUCTS CRBM SLIDES (K980283)Johnson & Johnson Clinical Diagnostics, Inc.1998-02-25
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS (K973535)Schiapparelli Biosystems, Inc.1997-10-20
CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY (K964765)Chiron Diagnostics Corp.1997-02-14
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS (K963673)Beckman Instruments, Inc.1997-02-04
CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (K964068)Bayer Corp.1996-12-13
CARBAMAZEPINE FLEX REAGENT CARTRIDGE (K962820)Dade Intl., Inc.1996-09-13
SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM (K955644)Beckman Instruments, Inc.1996-02-16
CARBAMAZEPINE EIA TEST (K955100)Diagnostic Reagents, Inc.1995-12-13
IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00 (K942687)Instrumentation Laboratory CO1995-01-25
AXSYM CARBAMAZEPHINE (K935374)Abbott Laboratories1994-06-21
QMS CARBAMAZEPINE ASSAY (K940374)Seradyn, Inc.1994-06-02
IL TEST CARBAMAZEPHINE (K933684)Instrumentation Laboratory CO1993-10-01
ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI (K926441)Roche Diagnostic Systems, Inc.1993-05-26
BIOTRACK CARBAMAZEPINE TEST CARTRIDGE (K915756)Biotrack, Inc.1992-07-23
CEDIA(R) CARBAMAZEPINE ASSAY (K914857)Microgenics Corp.1992-01-15
EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS (K913066)Syva Co.1991-07-30
ENZYMUN TEST(R) T4 (TOTAL THYROXINE) (K901086)Boehringer Mannheim Corp.1990-03-30
EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY (K897114)Syva Co.1990-01-18
OPUS CARBAMAZEPINE TEST SYSTEM (K896860)Pb Diagnostic Systems, Inc.1990-01-02
FPR CARBAMAZEPINE KIT (K894519)Colony Laboratories, Inc.1989-08-28
INNOFLUOR CARBAMAZEPINE REAGENT SET (K893507)Innotron of Oregon, Inc.1989-08-11
EMIT QST CARBAMAZEPINE ASSAY (K882961)Syva Co.1988-08-29
CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY (K873282)Windsor Laboratories, Inc.1987-09-22
ACCULEVEL CARBAMAZEPINE TEST (K871254)Syva Co.1987-06-17
EMIT CARBAMAZEPINE ASSAY (K871306)Syva Co.1987-04-14
SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT (K863842)Miles Laboratories, Inc.1987-01-14
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 (K864553)Em Diagnostic Systems, Inc.1987-01-08
EZ-SCREEN: CANNABINOID (K862916)Environmental Diagnostics, Inc.1987-01-07
DETERMINATION OF CARBAMAZEPINE (K860047)Clinical Data, Inc.1986-01-22
EMIT QST CARBAMAZEPINE ASSAY (K853835)Syva Co.1985-10-01
COBAS FP REAGENTS FOR CARBAMAZEPINE (K850807)Roche Diagnostic Systems, Inc.1985-03-22
CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT (K834052)Abbott Laboratories1984-01-24
EMIT AED CARBAMAZEPINE ASSAY (K832720)Syva Co.1983-10-04
AMES TDA DISOPYRAMIDE TEST (K832766)Miles Laboratories, Inc.1983-09-29
A-GENT CARBAMAZEPINE (K832631)Abbott Laboratories1983-09-12
STRATUS CARBAMAZEPINE FLUROMETRIC (K832447)American Dade1983-09-12
CARBAMEZEPINE REAGENT TEST KIT (K831222)Beckman Instruments, Inc.1983-05-09
CARBAMAZEPINE FLOURESCENT IMMUNOASSAY (K821945)American Diagnostic Corp.1982-07-16
CARBAMAZEPINE ASSAY (K820189)Syva Co.1982-02-12
AMES TDA CARBAMAZEPINE TEST (K811952)Miles Laboratories, Inc.1981-07-15
CYBREX CARBAMAZEPINE (K802902)Abbott Laboratories1980-12-19
EMIT AED ASSAYS 3500 COMPUTER DIRECTED (K790255)Syva Co.1979-03-02
ANALYTICAL TEST PACK, CARBAMAZEPINE (K781958)E.I. Dupont DE Nemours & Co., Inc.1979-01-10
EMIT CARBAMAZEPINE ASSAY (K780466)Syva Co.1978-04-24

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