SPECTROLYSE HEPARIN KIT— 510(k) K923499

Substantially Equivalent

Biopool AB

FDA 510(k) clearance K923499 for SPECTROLYSE HEPARIN KIT, Substantially Equivalent on 1994-01-27. Applicant: Biopool AB.

Clearance details

Applicant: Biopool AB
Product code: Code KFF
Advisory panel: Hematology
Date received: 1992-07-15
Decision date: 1994-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, L7l 6b8, CA

Download summary PDF View on FDA.gov ↗

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