CREATINE KINASE-MB REAGENT SET— 510(k) K971566

Name: FDA 510(k) clearance K971566
Creator: U.S. Food and Drug Administration
Published: 1997-07-14

Substantially Equivalent

Horizon Diagnostics, Inc.

FDA 510(k) clearance K971566 for CREATINE KINASE-MB REAGENT SET, Substantially Equivalent on 1997-07-14. Applicant: Horizon Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Horizon Diagnostics, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 1997-04-29
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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