HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B— 510(k) K041928

Name: FDA 510(k) clearance K041928
Creator: U.S. Food and Drug Administration
Published: 2004-11-23

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K041928 for HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B, Substantially Equivalent on 2004-11-23. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2004-07-19
Decision date: 2004-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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