CHOLESTEROL REAGENT SET ENZYMATIC— 510(k) K841053

Name: FDA 510(k) clearance K841053
Creator: U.S. Food and Drug Administration
Published: 1984-05-01

Substantially Equivalent

Medical Specialties, Inc.

FDA 510(k) clearance K841053 for CHOLESTEROL REAGENT SET ENZYMATIC, Substantially Equivalent on 1984-05-01. Applicant: Medical Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Medical Specialties, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1984-03-12
Decision date: 1984-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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