FDA 510(k) Applications Submitted by ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH

FDA 510(k) Number Submission Date Device Name Applicant
K981632 05/08/1998 ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
K983892 11/03/1998 COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH
K981931 06/02/1998 CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY ROCHE DIAGNOSTICS/BOEHRINGER MANNHEIM GMBH


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