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).
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Reference Product Name Price
510(k)
CE  /  HCL
224101
 BIOPHEN™ UFH Control C1 $377.00
510(k)
CE  /  HCL
224201
 BIOPHEN™ LMWH Control C4 $377.00
510(k)
CE  /  HCL
224301
 BIOPHEN™ LMWH Control Low Cl $377.00
510(k)
CE  /  HCL
RUO
223301
 BIOPHEN™ Abnormal Control Plasma (IVD) $377.00