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510(k) K050367

BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 by Hyphen Biomed — Product Code KFF

K050367 is an FDA 510(k) premarket notification submitted by Hyphen Biomed for the device "BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6". The FDA issued a decision of Substantially Equivalent on May 24, 2006. The device falls under product code KFF (Assay, Heparin), a Class II device regulated under 21 CFR 864.7525. Hyphen Biomed has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2006
Date Received
February 14, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Heparin
Device Class
Class II
Regulation Number
864.7525
Review Panel
HE
Submission Type

Other clearances by Hyphen Biomed

  • K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (September 7, 2007)
  • K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (December 27, 2005)
  • 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 KFF

  • K213464 — HemosIL Liquid Anti-Xa (October 4, 2022)
  • K162540 — INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Hep (August 22, 2017)
  • K111822 — STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / (October 26, 2011)
  • K090209 — HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS (June 2, 2009)
  • K013305 — ENOXAPARIN TEST CARD (August 23, 2002)
  • K013637 — ACTICHROME HEPARIN (ANTI-FIIA) (April 16, 2002)
  • K013318 — ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (March 8, 2002)
  • K010455 — ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (June 7, 2001)
  • K010193 — HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (June 6, 2001)
  • K983178 — COAMATIC HEPARIN (November 3, 1998)

FDA data resources