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510(k) K935169

APTT-ES by Helena Laboratories — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1994
Date Received
October 26, 1993
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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