HDL-CHOLESTEROL STANDARD, MODIFICATION— 510(k) K924904

Name: FDA 510(k) clearance K924904
Creator: U.S. Food and Drug Administration
Published: 1993-01-13

Substantially Equivalent

Verichem Laboratories, Inc.

FDA 510(k) clearance K924904 for HDL-CHOLESTEROL STANDARD, MODIFICATION, Substantially Equivalent on 1993-01-13. Applicant: Verichem Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Verichem Laboratories, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1992-09-29
Decision date: 1993-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Providence, RI, US

Download summary PDF View on FDA.gov ↗

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