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510(k) K014028

CARESIDE APTT by Careside Hemotology, Inc. — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2002
Date Received
December 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Partial Thromboplastin
Device Class
Class II
Regulation Number
864.7925
Review Panel
HE
Submission Type

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