ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE— 510(k) K964609

Name: FDA 510(k) clearance K964609
Creator: U.S. Food and Drug Administration
Published: 1997-03-06

Substantially Equivalent

Array 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.. Device class: 2.

Clearance details

Applicant: Array Medical, Inc.
Product code: Code JBP
Device class: Class 2
Regulation: 21 CFR 864.7140
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 ↗

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