JAS HDL CHOLESTEROL (AUTOMATED) REAGENT— 510(k) K021671

Name: FDA 510(k) clearance K021671
Creator: U.S. Food and Drug Administration
Published: 2002-07-19

Substantially Equivalent

Jas Diagnostics, Inc.

FDA 510(k) clearance K021671 for JAS HDL CHOLESTEROL (AUTOMATED) REAGENT, Substantially Equivalent on 2002-07-19. Applicant: Jas Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Jas Diagnostics, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2002-05-21
Decision date: 2002-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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