CLINISTAT HDL CHOLESTEROL REAGENT TEST— 510(k) K895139

Name: FDA 510(k) clearance K895139
Creator: U.S. Food and Drug Administration
Published: 1989-12-27

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K895139 for CLINISTAT HDL CHOLESTEROL REAGENT TEST, Substantially Equivalent on 1989-12-27. Applicant: Heraeus Kulzer, Inc.. Device class: 1.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1989-08-16
Decision date: 1989-12-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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