K964609

Substantially Equivalent

ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE

Applicant: Array Medical, Inc.
Product code: JBP
Advisory panel: Hematology
Date received: 1996-11-18
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bridgewater, NJ, US

Download summary PDF View on FDA.gov ↗

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