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510(k) K040293

HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAY by Akers Laboratories, Inc. — Product Code LCO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2004
Date Received
February 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Platelet Factor 4 Radioimmunoassay
Device Class
Class II
Regulation Number
864.7695
Review Panel
HE
Submission Type

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