HDL CHOLESTEROL AQUEOUS STANDARDS— 510(k) K840220

Name: FDA 510(k) clearance K840220
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Preventive Diagnostics Corp.

FDA 510(k) clearance K840220 for HDL CHOLESTEROL AQUEOUS STANDARDS, Substantially Equivalent on 1984-03-23. Applicant: Preventive Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Preventive Diagnostics Corp.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1984-01-19
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K840189 — TOTAL CHOLESTEROL REAGENT SET1984-03-23
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