HDL/CHOLESTEROL TEST SYSTEM— 510(k) K861244

Name: FDA 510(k) clearance K861244
Creator: U.S. Food and Drug Administration
Published: 1986-09-29

Substantially Equivalent

Chrometrics Laboratories, Inc.

FDA 510(k) clearance K861244 for HDL/CHOLESTEROL TEST SYSTEM, Substantially Equivalent on 1986-09-29. Applicant: Chrometrics Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Chrometrics Laboratories, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1986-04-02
Decision date: 1986-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

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