Premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).
Reference Product Name Price
510(k)
CE  /  HCL
223901
BIOPHEN UFH Control C2 $240.00
510(k)
CE  /  HCL
224401
BIOPHEN LMWH Control Low Cll $240.00
510(k)
CE  /  HCL
224101
BIOPHEN UFH Control C1 $240.00
510(k)
CE  /  HCL
224201
BIOPHEN LMWH Control C4 $240.00
510(k)
CE  /  HCL
224301
BIOPHEN LMWH Control Low Cl $240.00
510(k)
CE  /  HCL
RUO
223301
BIOPHEN Abnormal Control Plasma (IVD) $240.00