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

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..

Clearance details

Applicant
Horizon Diagnostics, Inc.
Product code
Code CGS
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.