Panels › Clinical Chemistry › Product code LFR · Class 2

Glucose Dehydrogenase, Glucose

Regulation 862.1345

0510(k)s in 12 months (73 all time)

0recalls in 12 months (51 all time)

43recalls that name a 510(k)

Top companies in LFR

Company	510(k)s	Recalls
Roche Diagnostics	12	37
Boehringer Mannheim Corp.	9	0
Bayer Healthcare	4	4
Abbott Diabetes Care, Inc.	5	2
Eps Bio Technology Corp.	6	0
Roche Diabetes Care, Inc.	0	5
Abbott Laboratories	4	0
Hemocue AB	4	0
Taidoc Technology Corporation	4	0
Emd Chemicals, Inc.	3	0

Date	Firm and product	Code	Linked 510(k)
Apr 9, 2003	Roche Diagnostics Corp. Accu-Chek Comfort Curve glucose test strips; part numbers 2030420, 2030365, 2030373, 2030381, 3000133 and 3000141. Terminated	LFR	K010362 K982002

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