CHOLESTEROL TEST SYSTEM— 510(k) K850390

Name: FDA 510(k) clearance K850390
Creator: U.S. Food and Drug Administration
Published: 1985-07-09

Substantially Equivalent

Hans J. Brouwers & Assoc.

FDA 510(k) clearance K850390 for CHOLESTEROL TEST SYSTEM, Substantially Equivalent on 1985-07-09. Applicant: Hans J. Brouwers & Assoc.. Device class: 1.

Clearance details

Applicant: Hans J. Brouwers & Assoc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1985-02-01
Decision date: 1985-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mount Prospect, IL, US

Download summary PDF View on FDA.gov ↗

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