Visulize Factor Ix Antigen Kit
FDA 510(k) K051054 · Affinity Biologicals, Inc.
510(k) numberK051054
Submission
- Device name
- Visulize Factor Ix Antigen Kit
- Applicant
- Affinity Biologicals, Inc.
Ancaster, Ontario, CA - Received
- April 26, 2005
- Decision date
- June 29, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGP – Test, Qualitative And Quantitative Factor Deficiency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7290
- Specialty
- Hematology
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Questions and answers
When was Visulize Factor Ix Antigen Kit cleared by the FDA?
Visulize Factor Ix Antigen Kit (K051054) received a 510(k) decision of Substantially Equivalent on June 29, 2005, 64 days after the submission was received.
What is the product code of K051054?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.