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510(k) K932145

COAGULATION REFERENCE PLASMA, NORMAL by American Diagnostic Corp. — Product Code GIZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1993
Date Received
May 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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