CLINISTAT TOTAL PROTEIN REAGENT TEST— 510(k) K896916

Name: FDA 510(k) clearance K896916
Creator: U.S. Food and Drug Administration
Published: 1990-01-19

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K896916 for CLINISTAT TOTAL PROTEIN REAGENT TEST, Substantially Equivalent on 1990-01-19. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1989-12-11
Decision date: 1990-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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