CHOLESTEROL HIGH SENSIT. REAGENT ENZYM— 510(k) K823187

Name: FDA 510(k) clearance K823187
Creator: U.S. Food and Drug Administration
Published: 1982-11-22

Substantially Equivalent

Rai, Inc.

FDA 510(k) clearance K823187 for CHOLESTEROL HIGH SENSIT. REAGENT ENZYM, Substantially Equivalent on 1982-11-22. Applicant: Rai, Inc.. Device class: 1.

Clearance details

Applicant: Rai, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1982-10-26
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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