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510(k) K051472

BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR by Hyphen Biomed — Product Code GGN

K051472 is an FDA 510(k) premarket notification submitted by Hyphen Biomed for the device "BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR". The FDA issued a decision of Substantially Equivalent on December 23, 2005. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Hyphen Biomed has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2005
Date Received
June 3, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Control
Device Class
Class II
Regulation Number
864.5425
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)
  • K050365 — BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 (December 27, 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 GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (June 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (March 16, 2017)
  • K161316 — George King Coumadin Plasma (February 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (January 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (June 3, 2016)
  • K150144 — VisuCon-F Low Fibrinogen Control Plasma (March 6, 2016)
  • K142132 — POOL NORM (December 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (August 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (July 3, 2013)
  • K120900 — I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 (May 31, 2013)

FDA data resources