COULTER DART CK-MB ISOENZYME REAGENT SYSTEM— 510(k) K872041

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K872041 for COULTER DART CK-MB ISOENZYME REAGENT SYSTEM, Substantially Equivalent on 1987-09-16. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code JHT
Advisory panel: Clinical Chemistry
Date received: 1987-05-27
Decision date: 1987-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

Download summary PDF View on FDA.gov ↗

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