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510(k) K944691

ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II by International Technidyne Corp. — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 1995
Date Received
September 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

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