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510(k) K020914

ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 by Helena Laboratories — Product Code JBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2002
Date Received
March 21, 2002
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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