Factor Viii Antibody Screen
FDA 510(k) K082205 · Genetic Testing Institute
510(k) numberK082205
Submission
- Device name
- Factor Viii Antibody Screen
- Applicant
- Genetic Testing Institute
Waukesha, WI, US - Received
- August 5, 2008
- Decision date
- November 20, 2008
- 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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|---|---|---|
| K071781 | PF4 IggLCO · Traditional | 12/19/2007SE |
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| K993553 | Gti-Fviii Inhibitor AssayGGP · Traditional | 02/01/2000SE |
| K983379 | GTI-PF4 ElisaLCO · Traditional | 03/09/1999SE |
| K841114 | Allo-Type Human Immunoglobulin-DGX · Traditional | 06/14/1984SE |
Questions and answers
When was Factor Viii Antibody Screen cleared by the FDA?
Factor Viii Antibody Screen (K082205) received a 510(k) decision of Substantially Equivalent on November 20, 2008, 107 days after the submission was received.
What is the product code of K082205?
The FDA product code is GGP – Test, Qualitative And Quantitative Factor Deficiency, a Class II (moderate risk) device regulated under 21 CFR 864.7290.