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)

Top companies in KLT

Company	510(k)s	Recalls
Syva Co.	12	0
Abbott Laboratories	5	0
Beckman Instruments, Inc.	3	0
Miles Laboratories, Inc.	3	0
Ortho-Clinical Diagnostics	0	3
Bayer Corp.	2	0
Instrumentation Laboratory CO	2	0
Microgenics Corp.	2	0
Roche Diagnostic Systems, Inc.	2	0
Abbott Laboratories HPD/ADD/GPRD	0	1

Decided	510(k)	Device and applicant	Code
Feb 12, 1982	K820189	CARBAMAZEPINE ASSAY Syva Co.	KLT
Jul 15, 1981	K811952	AMES TDA CARBAMAZEPINE TEST Miles Laboratories, Inc.	KLT
Dec 19, 1980	K802902	CYBREX CARBAMAZEPINE Abbott Laboratories	KLT
Mar 2, 1979	K790255	EMIT AED ASSAYS 3500 COMPUTER DIRECTED Syva Co.	KLT
Jan 10, 1979	K781958	ANALYTICAL TEST PACK, CARBAMAZEPINE E.I. Dupont DE Nemours & Co., Inc.	KLT
Apr 24, 1978	K780466	EMIT CARBAMAZEPINE ASSAY Syva Co.	KLT

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