Enzyme Immunoassay, Carbamazepine

FDA product code KLT · 55 cleared devices

Class 2 Clinical Toxicology

Regulation: 21 CFR 862.3645
Review panel: TX
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1978-04-24 – 2013-06-05

KLT 2013-06-05

ABBOTT CARBAMAZEPINE ASSAY

Applicant Microgenics Corporation

K number K123518

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KLT 2011-10-14

ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS

Applicant Abbott Laboratories

K number K103627

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KLT 2007-10-05

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS

Applicant Thermo Electron OY

K number K063131

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KLT 2005-02-08

ADVIA IMS CARBAMAZEPINE METHOD

Applicant Bayer Healthcare, LLC

K number K042808

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KLT 2003-09-17

ONLINE TDM CARBAMAZEPINE

Applicant Roche Diagnostics Corp.

K number K031902

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KLT 2002-01-15

RANDOX CARBAMAZEPINE

Applicant Randox Laboratories, Ltd.

K number K011648

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KLT 2001-04-13

EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229

Applicant Syva Co., Dade Behring, Inc.

K number K010814

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KLT 2000-05-18

ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM

Applicant Bayer Corp.

K number K000903

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KLT 2000-02-28

IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6

Applicant Diagnostic Products Corp.

K number K000007

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KLT 2000-01-27

SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL

Applicant Syva Co.

K number K993987

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KLT 2000-01-27

ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90

Applicant Syva Co.

K number K993028

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KLT 1998-02-25

VITROS CHEMISTRY PRODUCTS CRBM SLIDES

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K980283

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KLT 1997-10-20

ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS

Applicant Schiapparelli Biosystems, Inc.

K number K973535

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KLT 1997-02-14

CHIRON DIAGNOSTICS ACS: 180 CARBAMAZEPINE ASSAY

Applicant Chiron Diagnostics Corp.

K number K964765

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KLT 1997-02-04

IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS

Applicant Beckman Instruments, Inc.

K number K963673

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KLT 1996-12-13

CARBAMAZEPINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM

Applicant Bayer Corp.

K number K964068

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KLT 1996-09-13

CARBAMAZEPINE FLEX REAGENT CARTRIDGE

Applicant Dade Intl., Inc.

K number K962820

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KLT 1996-02-16

SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM

Applicant Beckman Instruments, Inc.

K number K955644

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KLT 1995-12-13

CARBAMAZEPINE EIA TEST

Applicant Diagnostic Reagents, Inc.

K number K955100

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KLT 1995-01-25

IL TEST CARBAMAZEPINE, PN 181754-00; IL TEST CARBAMAZEPINE CALIBRATORS, PN 181762-00

Applicant Instrumentation Laboratory CO

K number K942687

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KLT 1994-06-21

AXSYM CARBAMAZEPHINE

Applicant Abbott Laboratories

K number K935374

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KLT 1994-06-02

QMS CARBAMAZEPINE ASSAY

Applicant Seradyn, Inc.

K number K940374

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KLT 1993-10-01

IL TEST CARBAMAZEPHINE

Applicant Instrumentation Laboratory CO

K number K933684

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KLT 1993-05-26

ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI

Applicant Roche Diagnostic Systems, Inc.

K number K926441

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KLT 1992-07-23

BIOTRACK CARBAMAZEPINE TEST CARTRIDGE

Applicant Biotrack, Inc.

K number K915756

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KLT 1992-01-15

CEDIA(R) CARBAMAZEPINE ASSAY

Applicant Microgenics Corp.

K number K914857

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KLT 1991-07-30

EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS

Applicant Syva Co.

K number K913066

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KLT 1990-03-30

ENZYMUN TEST(R) T4 (TOTAL THYROXINE)

Applicant Boehringer Mannheim Corp.

K number K901086

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KLT 1990-01-18

EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K897114

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KLT 1990-01-02

OPUS CARBAMAZEPINE TEST SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K896860

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KLT 1989-08-28

FPR CARBAMAZEPINE KIT

Applicant Colony Laboratories, Inc.

K number K894519

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KLT 1989-08-11

INNOFLUOR CARBAMAZEPINE REAGENT SET

Applicant Innotron of Oregon, Inc.

K number K893507

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KLT 1988-08-29

EMIT QST CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K882961

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KLT 1987-09-22

CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY

Applicant Windsor Laboratories, Inc.

K number K873282

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KLT 1987-06-17

ACCULEVEL CARBAMAZEPINE TEST

Applicant Syva Co.

K number K871254

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KLT 1987-04-14

EMIT CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K871306

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KLT 1987-01-14

SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT

Applicant Miles Laboratories, Inc.

K number K863842

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KLT 1987-01-08

EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95

Applicant Em Diagnostic Systems, Inc.

K number K864553

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KLT 1987-01-07

EZ-SCREEN: CANNABINOID

Applicant Environmental Diagnostics, Inc.

K number K862916

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KLT 1986-01-22

DETERMINATION OF CARBAMAZEPINE

Applicant Clinical Data, Inc.

K number K860047

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KLT 1985-10-01

EMIT QST CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K853835

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KLT 1985-03-22

COBAS FP REAGENTS FOR CARBAMAZEPINE

Applicant Roche Diagnostic Systems, Inc.

K number K850807

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KLT 1984-01-24

CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT

Applicant Abbott Laboratories

K number K834052

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KLT 1983-10-04

EMIT AED CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K832720

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KLT 1983-09-29

AMES TDA DISOPYRAMIDE TEST

Applicant Miles Laboratories, Inc.

K number K832766

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KLT 1983-09-12

A-GENT CARBAMAZEPINE

Applicant Abbott Laboratories

K number K832631

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KLT 1983-09-12

STRATUS CARBAMAZEPINE FLUROMETRIC

Applicant American Dade

K number K832447

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KLT 1983-05-09

CARBAMEZEPINE REAGENT TEST KIT

Applicant Beckman Instruments, Inc.

K number K831222

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KLT 1982-07-16

CARBAMAZEPINE FLOURESCENT IMMUNOASSAY

Applicant American Diagnostic Corp.

K number K821945

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KLT 1982-02-12

CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K820189

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KLT 1981-07-15

AMES TDA CARBAMAZEPINE TEST

Applicant Miles Laboratories, Inc.

K number K811952

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KLT 1980-12-19

CYBREX CARBAMAZEPINE

Applicant Abbott Laboratories

K number K802902

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KLT 1979-03-02

EMIT AED ASSAYS 3500 COMPUTER DIRECTED

Applicant Syva Co.

K number K790255

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KLT 1979-01-10

ANALYTICAL TEST PACK, CARBAMAZEPINE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K781958

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KLT 1978-04-24

EMIT CARBAMAZEPINE ASSAY

Applicant Syva Co.

K number K780466

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