CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL— 510(k) K792377

Name: FDA 510(k) clearance K792377
Creator: U.S. Food and Drug Administration
Published: 1980-09-26

Substantially Equivalent

Environmental Chemical Specialties

FDA 510(k) clearance K792377 for CARCINOEMBRYONIC ANTIGEN (CEA) CONTROL, Substantially Equivalent on 1980-09-26. Applicant: Environmental Chemical Specialties. Device class: 2.

Clearance details

Applicant: Environmental Chemical Specialties
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1979-11-26
Decision date: 1980-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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