CREATINE KINASE REAGENT CK LTS— 510(k) K831965

Name: FDA 510(k) clearance K831965
Creator: U.S. Food and Drug Administration
Published: 1983-09-12

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K831965 for CREATINE KINASE REAGENT CK LTS, Substantially Equivalent on 1983-09-12. Applicant: Electro-Nucleonics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1983-06-20
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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