GJT — Plasma, Coagulation Factor Deficient Class II
FDA product code GJT covers "Plasma, Coagulation Factor Deficient", 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
- GJT
- 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 |
|---|---|---|---|
| K222831 | precision biologic | CRYOcheck Factor VIII Deficient Plasma with VWF | September 13, 2023 |
| K180486 | instrumentation laboratory | HemosIL Factor XII Deficient Plasma | March 22, 2018 |
| K102851 | r2 diagnostics | NOFACT VIII | December 19, 2011 |
| K102908 | r2 diagnostics | NOFACT IX | December 19, 2011 |
| K110237 | instrumentation laboratory | HEMOSIL FACTOR VIII DEFICIENT PLASMA | July 8, 2011 |
| K050661 | instrumentation laboratory | HEMOSIL FACTOR II DEFICIENT PLASMA | May 2, 2005 |
| K043459 | instrumentation laboratory | HEMOSIL FACTOR XII DEFICIENT PLASMA | February 9, 2005 |
| K040362 | diapharma group | DIAPHARMA FACTOR X KIT | July 12, 2004 |
| K034007 | instrumentation laboratory | HEMOSIL FACTOR VIII DEFICIENT PLASMA | February 13, 2004 |
| K031829 | instrumentation laboratory | HEMOSIL FACTOR IX DEFICIENT PLASMA | July 31, 2003 |
| K031122 | instrumentation laboratory | HEMOSIL FACTOR X DEFICIENT PLASMA | May 19, 2003 |
| K030287 | instrumentation laboratory | HEMOSIL FACTOR XI DEFICIENT PLASMA | March 19, 2003 |
| K024082 | instrumentation laboratory | HEMOSIL FACTOR VII DEFICIENT PLASMA | February 12, 2003 |
| K023839 | instrumentation laboratory | HEMOSIL FACTOR V DEFICIENT PLASMA | January 14, 2003 |
| K990814 | precision biologic | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | June 7, 1999 |
| K990296 | precision biologic | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10 | March 18, 1999 |
| K990046 | pacific hemostasis | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | February 17, 1999 |
| K981174 | precision biologicals | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5M | January 13, 1999 |
| K981173 | precision biologicals | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5M | January 13, 1999 |
| K981709 | dade behring | COAGULATION FACTOR V DEFICIENT PLASMA | October 13, 1998 |