TOTAL CHOLESTEROL REAGENT SET— 510(k) K840189

Name: FDA 510(k) clearance K840189
Creator: U.S. Food and Drug Administration
Published: 1984-03-23

Substantially Equivalent

Preventive Diagnostics Corp.

FDA 510(k) clearance K840189 for TOTAL CHOLESTEROL REAGENT SET, Substantially Equivalent on 1984-03-23. Applicant: Preventive Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Preventive Diagnostics Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1984-01-18
Decision date: 1984-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K840217 — CHOLESTEROL AQUEOUS STANDARD1984-03-23
K840218 — TRIGLYCERIDE AQUEOUS STANDARDS1984-03-23
K840219 — TRIGLYCERIDE/CHOLESTEROL AQUEOUS1984-03-23

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