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510(k) K043451

BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR by Hyphen Biomed — Product Code GGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2005
Date Received
December 14, 2004
Clearance Type
Abbreviated
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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