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 | ||
|
|
223901
|
BIOPHEN™ UFH Control C2 | $350.00 | |
|
|
224401
|
BIOPHEN™ LMWH Control Low Cll | $350.00 | |
|
|
224101
|
BIOPHEN™ UFH Control C1 | $350.00 | |
|
|
224201
|
BIOPHEN™ LMWH Control C4 | $350.00 | |
|
|
224301
|
BIOPHEN™ LMWH Control Low Cl | $350.00 | |
|
|
223301
|
BIOPHEN™ Abnormal Control Plasma (IVD) | $350.00 |