Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn
FDA 510(k) K110432 · Affinity Biologicals, Inc.
510(k) numberK110432
Submission
- Device name
- Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn
- Applicant
- Affinity Biologicals, Inc.
Ancaster, Ontario, CA - Received
- February 15, 2011
- Decision date
- October 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K161316 | George King Coumadin PlasmaGGN · Traditional | George King Bio-Medical, Inc. | 02/23/2017SE |
| K162705 | VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitGGN · Traditional | Maine Standards Company, LLC | 01/05/2017SE |
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| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | Affinity Biologicals, Inc. | 03/06/2016SE |
| K142132 | Pool NormGGN · Traditional | Diagnostics Stago S.A.S. | 12/12/2014SE |
| K133582 | Hemosil D-Dimer HS 500 ControlGGN · Traditional | Instrumentation Laboratory | 08/15/2014SE |
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | International Technidyne Corp. | 07/03/2013SE |
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | Cliniqa Corporation | 05/31/2013SE |
More from Cliniqa Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | 03/06/2016SE |
| K091284 | Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaGGN · Traditional | 10/28/2009SE |
| K052825 | Visulize Factor Viii Antigen Kit, Model Fviii-AgGGP · Traditional | 01/20/2006SE |
| K051054 | Visulize Factor Ix Antigen KitGGP · Traditional | 06/29/2005SE |
Questions and answers
When was Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn cleared by the FDA?
Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (K110432) received a 510(k) decision of Substantially Equivalent on October 20, 2011, 247 days after the submission was received.
What is the product code of K110432?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.