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510(k) K150144

VisuCon-F Low Fibrinogen Control Plasma by Affinity Biologicals, Inc. — Product Code GGN

K150144 is an FDA 510(k) premarket notification submitted by Affinity Biologicals, Inc. for the device "VisuCon-F Low Fibrinogen Control Plasma". The FDA issued a decision of Substantially Equivalent on March 6, 2016. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Affinity Biologicals, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2016
Date Received
January 22, 2015
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 Affinity Biologicals, Inc.

  • K110432 — VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN (October 20, 2011)
  • K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONT (October 28, 2009)
  • K052825 — VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG (January 20, 2006)
  • K051054 — VISULIZE FACTOR IX ANTIGEN KIT (June 29, 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)
  • 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)
  • K120014 — STA- COAG CONTROL (N+ABN) PLUS (March 14, 2013)

FDA data resources