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510(k) K013078

ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 by Helena Laboratories — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 2002
Date Received
September 14, 2001
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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