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510(k) K050365

BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 by Hyphen Biomed — Product Code GGP

K050365 is an FDA 510(k) premarket notification submitted by Hyphen Biomed for the device "BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202". The FDA issued a decision of Substantially Equivalent on December 27, 2005. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Hyphen Biomed has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 2005
Date Received
February 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Qualitative And Quantitative Factor Deficiency
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by Hyphen Biomed

  • K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (September 7, 2007)
  • K050367 — BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 (May 24, 2006)
  • K051472 — BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CA (December 23, 2005)
  • K043007 — BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE (November 7, 2005)
  • K043451 — BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR (March 17, 2005)

Other clearances for product code GGP

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K230852 — HemosIL Chromogenic Factor IX (December 13, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K223402 — HemosIL von Willebrand Factor Antigen (December 9, 2022)
  • K200033 — HemosIL von Willebrand Factor Antigen (August 19, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K181525 — INNOVANCE Free PS Ag (September 7, 2018)
  • K133005 — HEMOSIL VON WILLEBRAND ACTIVITY ASSAY (March 13, 2014)

FDA data resources