VisuCon-F Low Fibrinogen Control Plasma
FDA 510(k) K150144 · Affinity Biologicals, Inc.
510(k) numberK150144
Submission
- Device name
- VisuCon-F Low Fibrinogen Control Plasma
- Applicant
- Affinity Biologicals, Inc.
Ancaster, CA - Received
- January 22, 2015
- Decision date
- March 6, 2016
- 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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More from Diagnostica Stago, Inc.
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|---|---|---|
| K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnGGN · Traditional | 10/20/2011SE |
| 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 Low Fibrinogen Control Plasma cleared by the FDA?
VisuCon-F Low Fibrinogen Control Plasma (K150144) received a 510(k) decision of Substantially Equivalent on March 6, 2016, 409 days after the submission was received.
What is the product code of K150144?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.