DeviceClearance

CLINISTAT TOTAL BILIRUBIN REAGENT TEST— 510(k) K892801

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K892801 for CLINISTAT TOTAL BILIRUBIN REAGENT TEST, Substantially Equivalent on 1989-08-15. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant
Heraeus Kulzer, Inc.
Product code
Code CIG
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Elkhart, IN, US
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