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)
A224201
 BIOPHEN™ LMWH Control C4 — LMWH QC Plasma ~1.20 IU/mL $175.00
510(k)
A224301
 BIOPHEN™ LMWH Control Low CI — LMWH QC Plasma ~0.25 IU/mL $175.00
510(k)
A223301
 BIOPHEN™ Abnormal Control Plasma — Multi-Parameter QC (Pathological) $175.00