TOTAL PROTEIN TEST— 510(k) K801061

Name: FDA 510(k) clearance K801061
Creator: U.S. Food and Drug Administration
Published: 1980-07-21

Substantially Equivalent

Environmental Chemical Specialties

FDA 510(k) clearance K801061 for TOTAL PROTEIN TEST, Substantially Equivalent on 1980-07-21. Applicant: Environmental Chemical Specialties. Device class: 2.

Clearance details

Applicant: Environmental Chemical Specialties
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1980-05-06
Decision date: 1980-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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