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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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