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510(k) K060688

HEMOSIL SYNTHASIL by Instrumentation Laboratory CO — Product Code GFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2006
Date Received
March 15, 2006
Clearance Type
Special
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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  • K022021 — VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT (November 1, 2002)
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