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)
A221006
 BIOPHEN™ Heparin 6 — Anti-Xa Assay for UFH/LMWH/Analogues $439.00
510(k)
A221102
 BIOPHEN™ Antithrombin 2.5 — AT Activity Anti-Xa Chromogenic Assay $92.00
510(k)
A221105
 BIOPHEN™ Antithrombin 5 — AT Activity Anti-Xa Chromogenic Assay Discontinued
510(k)
A221205
 BIOPHEN™ Protein C 5 — Chromogenic PC Activity Assay $714.00
510(k)
ARK040A
 ZYMUTEST™ HIA IgG — IgG Heparin-PF4 Antibody ELISA for HIT $999.00
510(k)
ARK040D
 ZYMUTEST™ HIA IgGAM — Pan-Isotype HIT Screening ELISA (IgG/IgA/IgM) $999.00
510(k)
ARK041A
 ZYMUTEST™ HIA MonoStrip IgG — Strip ELISA for HIT Antibody $549.00
510(k)
ACK065K
 HEMOCLOT™ Quanti.VL — Quantitative APC Resistance / Factor V Leiden $385.00
510(k)
A222401
 BIOPHEN™ V-L Plasma Calibrator — Factor V Leiden Quantitative Calibrator $102.00
510(k)
A222001
 BIOPHEN™ Heparin Calibrator — 5-Level LMWH Anti-Xa Calibration Set $245.00
510(k)
A222301
 BIOPHEN™ UFH Calibrator — 5-Level UFH Anti-Xa Calibration Set $255.00
510(k)
A222101
 BIOPHEN™ Plasma Calibrator — Multi-Factor Calibration Standard $318.00
510(k)
A223201
 BIOPHEN™ Normal Control Plasma — Multi-Parameter QC (22 Analytes) $175.00
510(k)
A223001
 BIOPHEN™ LMWH Control Plasma — LMWH Anti-Xa QC (High Range) $175.00
510(k)
A223101
 BIOPHEN™ UFH Control Plasma — UFH Anti-Xa Quality Control $175.00
510(k)
A223405
 BIOPHEN™ V-L Control Plasma — Factor V Leiden QC (Heterozygous APC-R) $175.00
510(k)
A223701
 BIOPHEN™ LMWH Control Low — LMWH Anti-Xa QC (Low Range) $175.00
510(k)
A223801
 BIOPHEN™ LMWH Control C3 — LMWH QC Plasma ~0.80 IU/mL $175.00
510(k)
A223901
 BIOPHEN™ UFH Control C2 — UFH QC Plasma ~0.50 IU/mL $175.00
510(k)
A224401
 BIOPHEN™ LMWH Control Low CII — LMWH QC Plasma ~0.50 IU/mL $175.00