K981883

Substantially Equivalent

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844

Applicant: Boehringer Mannheim Corp.
Product code: CIG
Advisory panel: Clinical Chemistry
Date received: 1998-05-29
Decision date: 1998-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.