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510(k) K964609

ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE by Array Medical, Inc. — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1997
Date Received
November 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
Review Panel
HE
Submission Type

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