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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 Mar 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
Mar 6, 2016
Date Received
Jan 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 (Oct 20, 2011)
  • K091284 — VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONT (Oct 28, 2009)
  • K052825 — VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG (Jan 20, 2006)
  • K051054 — VISULIZE FACTOR IX ANTIGEN KIT (Jun 29, 2005)

Other clearances for product code GGN

  • K170864 — VALIDATE D-Dimer Calibration Verification / Linearity Test Kit (Jun 21, 2017)
  • K163498 — VALIDATE Heparin Calibration Verification/Linearity Test Kit (Mar 16, 2017)
  • K161316 — George King Coumadin Plasma (Feb 23, 2017)
  • K162705 — VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit (Jan 5, 2017)
  • K152961 — VALIDATE D-Dimer Calibration Verification/Linearity Test Kit (Jun 3, 2016)
  • K142132 — POOL NORM (Dec 12, 2014)
  • K133582 — HEMOSIL D-DIMER HS 500 CONTROL (Aug 15, 2014)
  • K120977 — DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DI (Jul 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 (Mar 14, 2013)

FDA data resources