GGP — Test, Qualitative And Quantitative Factor Deficiency Class II
FDA product code GGP covers "Test, Qualitative And Quantitative Factor Deficiency", a Class II medical device regulated under 21 CFR 864.7290. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GGP
- Device Class
- Class II
- Regulation Number
- 864.7290
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251440 | precision biologic | CRYOcheck Chromogenic Factor VIII | August 25, 2025 |
| K230852 | instrumentation laboratory | HemosIL Chromogenic Factor IX | December 13, 2023 |
| K220728 | siemens healthcare diagnostics products | vWF Ag | June 2, 2023 |
| K214002 | precision biologic | CRYOcheck Chromogenic Factor IX | December 23, 2022 |
| K223402 | instrumentation laboratory | HemosIL von Willebrand Factor Antigen | December 9, 2022 |
| K200033 | instrumentation laboratory | HemosIL von Willebrand Factor Antigen | August 19, 2020 |
| K193204 | precision biologic | Cryocheck Chromogenic Factor VIII | July 17, 2020 |
| K183440 | precision biologic | CRYOcheck FVIII Inhibitor Kit | March 12, 2019 |
| K181525 | siemens healthcare diagnostics products | INNOVANCE Free PS Ag | September 7, 2018 |
| K133005 | instrumentation laboratory | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | March 13, 2014 |
| K102164 | instrumentation laboratory | HEMOSIL PROTEIN S ACTIVITY ASSAY | March 17, 2011 |
| K092170 | diagnostica stago | STA LIATEST FREE PS | December 22, 2009 |
| K082631 | r2 diagnostics | THROMBO TEK PSE, MODEL 90-480 | December 17, 2008 |
| K082205 | genetic testing institute | FACTOR VIII ANTIBODY SCREEN | November 20, 2008 |
| K063323 | american diagnostica | SPECTROLYSE PAI-1, MODEL 101201 | August 15, 2007 |
| K070635 | instrumentation laboratory | HEMOSIL PROCLOT | March 29, 2007 |
| K062530 | biosite incorporated | TRIAGE PROTEIN C TEST | January 29, 2007 |
| K062430 | instrumentation laboratory | HEMOSIL PROTEIN C | September 1, 2006 |
| K052825 | affinity biologicals | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | January 20, 2006 |
| K053499 | instrumentation laboratory | HEMOSIL PROS | January 13, 2006 |