GFO — Activated Partial Thromboplastin Class II
FDA product code GFO covers "Activated Partial Thromboplastin", a Class II medical device regulated under 21 CFR 864.7925. 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
- GFO
- Device Class
- Class II
- Regulation Number
- 864.7925
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253957 | instrumentation laboratory (il) | HemosIL Silica Clotting Time | January 9, 2026 |
| K193556 | precision biologic | Cryocheck Hex LA | October 23, 2020 |
| K160445 | instrumentation laboratory | HemosIL Silica Clotting Time | March 16, 2016 |
| K053111 | diagnostica stago | STA-CEPHASCREEN KIT | May 4, 2006 |
| K060688 | instrumentation laboratory | HEMOSIL SYNTHASIL | April 13, 2006 |
| K050221 | instrumentation laboratory | HEMOSIL SILICA CLOTTING TIME | March 30, 2005 |
| K022021 | vital scientific n.v | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | November 1, 2002 |
| K014028 | careside hemotology | CARESIDE APTT | February 8, 2002 |
| K014008 | itc | HEMOCHRON JR. CITRATE APTT CUVETTE | January 24, 2002 |
| K992712 | sigma diagnostics | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | December 6, 1999 |
| K992711 | sigma diagnostics | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | December 6, 1999 |
| K972831 | international technidyne | HEMOCHRON CITRATE APTT | November 20, 1997 |
| K973306 | instrumentation laboratory | IL TEST APTT-SP | November 4, 1997 |
| K961892 | analytical control systems | SPECKTIN-LA TEST SET | March 7, 1997 |
| K955638 | ortho diagnostic systems | SYNTHAFAX APTT REAGENT | April 23, 1996 |
| K955450 | behring diagnostics | PATHROMTIN SL | April 19, 1996 |
| K953981 | ortho diagnostic systems | SYNTHASIL APTT REAGENT | November 30, 1995 |
| K935169 | helena laboratories | APTT-ES | December 2, 1994 |
| K934351 | medical diagnostic technologies | APTT-ES REAGENT | December 6, 1993 |
| K932011 | behring diagnostics | PATHROMTIN | October 25, 1993 |