BECKMAN CHOLESTEROL REAGENT— 510(k) K934046

Name: FDA 510(k) clearance K934046
Creator: U.S. Food and Drug Administration
Published: 1993-10-28

Substantially Equivalent

Beckman-Diagnostic Systems Group

FDA 510(k) clearance K934046 for BECKMAN CHOLESTEROL REAGENT, Substantially Equivalent on 1993-10-28. Applicant: Beckman-Diagnostic Systems Group. Device class: 1.

Clearance details

Applicant: Beckman-Diagnostic Systems Group
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1993-08-19
Decision date: 1993-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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