K971566

Substantially Equivalent

CREATINE KINASE-MB REAGENT SET

Applicant: Horizon Diagnostics, Inc.
Product code: CGS
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 ↗

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