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
- 510(k)
- 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 | Sep 13, 2023 |
| K180486 | Instrumentation Laboratory | HemosIL Factor XII Deficient Plasma | Mar 22, 2018 |
| K102851 | R2 Diagnostics | NOFACT VIII | Dec 19, 2011 |
| K102908 | R2 Diagnostics | NOFACT IX | Dec 19, 2011 |
| K110237 | Instrumentation Laboratory | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Jul 8, 2011 |
| K050661 | Instrumentation Laboratory | HEMOSIL FACTOR II DEFICIENT PLASMA | May 2, 2005 |
| K043459 | Instrumentation Laboratory | HEMOSIL FACTOR XII DEFICIENT PLASMA | Feb 9, 2005 |
| K040362 | Diapharma Group | DIAPHARMA FACTOR X KIT | Jul 12, 2004 |
| K034007 | Instrumentation Laboratory | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Feb 13, 2004 |
| K031829 | Instrumentation Laboratory | HEMOSIL FACTOR IX DEFICIENT PLASMA | Jul 31, 2003 |
| K031122 | Instrumentation Laboratory | HEMOSIL FACTOR X DEFICIENT PLASMA | May 19, 2003 |
| K030287 | Instrumentation Laboratory | HEMOSIL FACTOR XI DEFICIENT PLASMA | Mar 19, 2003 |
| K024082 | Instrumentation Laboratory | HEMOSIL FACTOR VII DEFICIENT PLASMA | Feb 12, 2003 |
| K023839 | Instrumentation Laboratory | HEMOSIL FACTOR V DEFICIENT PLASMA | Jan 14, 2003 |
| K990814 | Precision Biologic | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Jun 7, 1999 |
| K990296 | Precision Biologic | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML)… | Mar 18, 1999 |
| K990046 | Pacific Hemostasis | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Feb 17, 1999 |
| K981173 | Precision Biologicals | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15… | Jan 13, 1999 |
| K981174 | Precision Biologicals | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15… | Jan 13, 1999 |
| K981709 | Dade Behring | COAGULATION FACTOR V DEFICIENT PLASMA | Oct 13, 1998 |