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
221003
BIOPHEN™ Heparin 3 $355.00
510(k)
CE  /  HCL
221006
BIOPHEN™ Heparin 6 $755.00
510(k)
CE  /  HCL
221102
BIOPHEN™ Antithrombin 2.5 $215.00
510(k)
CE  /  HCL
221105
BIOPHEN™ Antithrombin 5 $535.00
510(k)
CE  /  HCL
221205
BIOPHEN™ Protein C 5 $1,300.00
510(k)
CE  /  HCL
RK040A
ZYMUTEST™ HIA IgG $785.00
510(k)
CE  /  HCL
RK040D
ZYMUTEST™ HIA IgGAM $785.00
510(k)
CE  /  HCL
RK041A
ZYMUTEST™ HIA MonoStrip IgG $430.00
510(k)
CE  /  HCL
RK041D
ZYMUTEST™ HIA MonoStrip IgGAM $430.00
510(k)
CE  /  HCL
CK065K
HEMOCLOT™ Quanti-V-L $625.00
510(k)
CE  /  HCL
222401
BIOPHEN™ V-L Plasma Calibrator $245.00
510(k)
CE  /  HCL
222001
BIOPHEN™ Heparin Calibrator $470.00
510(k)
CE  /  HCL
222301
BIOPHEN™ UFH Calibrator $460.00
510(k)
CE  /  HCL
RUO
222101
BIOPHEN™ Plasma Calibrator $595.00
510(k)
CE  /  HCL
RUO
223201
BIOPHEN™ Normal Control Plasma (IVD) $300.00
510(k)
CE  /  HCL
223001
BIOPHEN™ LMWH Control Plasma $300.00
510(k)
CE  /  HCL
223101
BIOPHEN™ UFH Control Plasma $300.00
510(k)
CE  /  HCL
223405
BIOPHEN™ V-L Control Plasma $320.00
510(k)
CE  /  HCL
223701
BIOPHEN™ LMWH Control Low $300.00
510(k)
CE  /  HCL
223801
BIOPHEN™ LMWH Control C3 $300.00