ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE— 510(k) K964609
Substantially EquivalentArray Medical, Inc.
FDA 510(k) clearance K964609 for ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE, Substantially Equivalent on 1997-03-06. Applicant: Array Medical, Inc..
Clearance details
- Applicant
- Array Medical, Inc.
- Product code
- Code JBP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgewater, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.