CLINISTAT CHOLESTEROL REAGENT TEST— 510(k) K884757

Name: FDA 510(k) clearance K884757
Creator: U.S. Food and Drug Administration
Published: 1989-03-10

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K884757 for CLINISTAT CHOLESTEROL REAGENT TEST, Substantially Equivalent on 1989-03-10. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1988-11-14
Decision date: 1989-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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