Panels › Clinical Chemistry › Product code CGA · Class 2

Glucose Oxidase, Glucose

Regulation 862.1345

1510(k)s in 12 months (401 all time)

0recalls in 12 months (89 all time)

79recalls that name a 510(k)

Top companies in CGA

Company	510(k)s	Recalls
Lifescan, Inc.	21	5
Roche Diagnostics Corp.	3	20
Boehringer Mannheim Corp.	17	0
Apex BioTechnology Corp.	14	0
Abbott Point of Care, Inc.	6	6
Miles Laboratories, Inc.	12	0
Nova Biomedical Corp.	7	5
Instrumentation Laboratory CO	9	2
Medisense, Inc.	11	0
Heraeus Kulzer, Inc.	10	0

Decided	510(k)	Device and applicant	Code
Oct 5, 1976	K760347	SET, TRINDER GLUCOSE Princeton Biomedix	CGA

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