Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma
FDA 510(k) K091284 · Affinity Biologicals, Inc.
510(k) numberK091284
Submission
- Device name
- Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma
- Applicant
- Affinity Biologicals, Inc.
Ancaster, Ontario, CA - Received
- May 1, 2009
- Decision date
- October 28, 2009
- 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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| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | Affinity Biologicals, Inc. | 03/06/2016SE |
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More from Cliniqa Corporation
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|---|---|---|
| K150144 | VisuCon-F Low Fibrinogen Control PlasmaGGN · Traditional | 03/06/2016SE |
| K110432 | Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen AbnGGN · Traditional | 10/20/2011SE |
| 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 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma cleared by the FDA?
Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma (K091284) received a 510(k) decision of Substantially Equivalent on October 28, 2009, 180 days after the submission was received.
What is the product code of K091284?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.