CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE)— 510(k) K864359

Name: FDA 510(k) clearance K864359
Creator: U.S. Food and Drug Administration
Published: 1987-02-06

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K864359 for CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE), Substantially Equivalent on 1987-02-06. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1986-11-03
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

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