ENZYMATIC CHOLESTEROL REAGENT SET— 510(k) K770909

Name: FDA 510(k) clearance K770909
Creator: U.S. Food and Drug Administration
Published: 1977-07-14

Substantially Equivalent

American Monitor Corp.

FDA 510(k) clearance K770909 for ENZYMATIC CHOLESTEROL REAGENT SET, Substantially Equivalent on 1977-07-14. Applicant: American Monitor Corp.. Device class: 1.

Clearance details

Applicant: American Monitor Corp.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-05-19
Decision date: 1977-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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