Panels › Clinical Toxicology › Product code LAN · Class 2

Enzyme Immunoassay, N-Acetylprocainamide

Regulation 862.3320

0510(k)s in 12 months (21 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

Top companies in LAN

Company	510(k)s	Recalls
Syva Co.	5	0
Abbott Laboratories	2	0
American Dade	2	0
Roche Diagnostic Systems, Inc.	2	0
Bayer Corp.	1	0
Dade Behring, Inc.	1	0
Diagnostic Reagents, Inc.	1	0
E.I. Dupont DE Nemours & Co., Inc.	1	0
Em Diagnostic Systems, Inc.	1	0
Miles Laboratories, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Sep 8, 2010	Roche Diagnostics Operations, Inc. ONLINE TDM N-acetylprocainamide, Part number 04642520190 N- acetylprocainamide reagent Roche Diagnostics Corporation Indianapolis, IN. Terminated	LAN	K060738

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