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Roche Diagnostics/Boehringer Mannheim GmbH

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K983892	COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P	JPA	1999-04-13	View
510(k)	K981931	CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY	CGN	1998-08-25	View
510(k)	K981632	ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT	CIG	1998-06-15	View

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