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 $295.00
510(k)
CE  /  HCL
221006
BIOPHEN Heparin 6 $595.00
510(k)
CE  /  HCL
221102
BIOPHEN Antithrombin 2.5 $170.00
510(k)
CE  /  HCL
221105
BIOPHEN Antithrombin 5 $425.00
510(k)
CE  /  HCL
221205
BIOPHEN Protein C 5 $985.00
510(k)
CE  /  HCL
RK040A
ZYMUTEST HIA IgG $650.00
510(k)
CE  /  HCL
RK040D
ZYMUTEST HIA IgGAM $650.00
510(k)
CE  /  HCL
RK041A
ZYMUTEST HIA MonoStrip IgG Price Inquiry
510(k)
CE  /  HCL
RK041D
ZYMUTEST HIA MonoStrip IgGAM Price Inquiry
510(k)
CE  /  HCL
CK065K
HEMOCLOT Quanti-V-L $475.00
510(k)
CE  /  HCL
222401
BIOPHEN V-L CAL (undiluted) $195.00
510(k)
CE  /  HCL
222001
BIOPHEN Heparin Calibrator $380.00
510(k)
CE  /  HCL
222301
BIOPHEN UFH Calibrator $380.00
510(k)
CE  /  HCL
RUO
222101
BIOPHEN Plasma Calibrator $480.00
510(k)
CE  /  HCL
RUO
223201
BIOPHEN Normal Control Plasma (IVD) $240.00
510(k)
CE  /  HCL
223001
BIOPHEN LMWH Control Plasma $240.00
510(k)
CE  /  HCL
223101
BIOPHEN UFH Control Plasma $240.00
510(k)
CE  /  HCL
223405
BIOPHEN Act. PC-r Control Plasma $270.00
510(k)
CE  /  HCL
223701
BIOPHEN LMWH Control Low $240.00
510(k)
CE  /  HCL
223801
BIOPHEN LMWH Control C3 $240.00