FDA 510(k), K052697, HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

FDA 510(k), K052697, HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL

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510(K) Number: K052697
Device Name: HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
Manufacturer: BARBARA A BAGBY
Device Classification Name: Plasma, Coagulation Control
Regulation Number: GGN
Classification Product Code: 09/28/2005
Date Received: 01/04/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Hematology
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