ClearanceBrief
Panels › Clinical Toxicology › Product code KLT · Class 2

Enzyme Immunoassay, Carbamazepine

Regulation 862.3645

0510(k)s in 12 months (56 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
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Top companies in KLT

Company510(k)sRecalls
Syva Co.120
Abbott Laboratories50
Beckman Instruments, Inc.30
Miles Laboratories, Inc.30
Ortho-Clinical Diagnostics03
Bayer Corp.20
Instrumentation Laboratory CO20
Microgenics Corp.20
Roche Diagnostic Systems, Inc.20
Abbott Laboratories HPD/ADD/GPRD01
DateFirm and productCodeLinked 510(k)
Apr 17, 2014Ortho-Clinical Diagnostics
VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products CRBM Slides quantitatively measure carbamaze
Terminated		 KLTK980283
Nov 15, 2013Ortho-Clinical Diagnostics
VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog number 8892382
Terminated		 KLTK980283
Jul 16, 2005Ortho-Clinical Diagnostics
Vitros Chemistry CRBM Slides, REF 889 2382. There are 90 slides per box. For in vitro diagnostic use. Firm on label: Ortho-Clinical Diagnostics, Inc., Rochester, NY 14626.
Terminated		 KLTK980283
Jul 20, 2004Beckman Coulter Inc
Synchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Terminated		 KLTK955644
Jul 20, 2004Abbott Laboratories HPD/ADD/GPRD
Package Insert for TDx/TDxFLx and TDxFLx Carbamazepine Reagents, REF 9515, item number 69-5121/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
Terminated		 KLTK802902

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