DeviceClearance

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT— 510(k) K981632

Substantially Equivalent

Roche Diagnostics/Boehringer Mannheim GmbH

FDA 510(k) clearance K981632 for ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 1998-06-15. Applicant: Roche Diagnostics/Boehringer Mannheim GmbH.

Clearance details

Applicant
Roche Diagnostics/Boehringer Mannheim GmbH
Product code
Code CIG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
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