CHOLESTEROL KIT— 510(k) K771067

Name: FDA 510(k) clearance K771067
Creator: U.S. Food and Drug Administration
Published: 1977-07-21

Substantially Equivalent

Environmental Chemical Specialties

FDA 510(k) clearance K771067 for CHOLESTEROL KIT, Substantially Equivalent on 1977-07-21. Applicant: Environmental Chemical Specialties. Device class: 1.

Clearance details

Applicant: Environmental Chemical Specialties
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 1977-06-13
Decision date: 1977-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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