GJT · Plasma, Coagulation Factor Deficient
Hematology · 21 CFR 864.7290 · Class 2
Overview
| Product Code | GJT |
|---|---|
| Device Name | Plasma, Coagulation Factor Deficient |
| Regulation | 21 CFR 864.7290 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Recent Cleared Devices (20 of 79)
Showing 20 most recent of 79 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | Sep 13, 2023 | SESE |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | Mar 22, 2018 | SESE |
| K102908 | NOFACT IX | R2 Diagnostics, Inc. | Dec 19, 2011 | SESE |
| K102851 | NOFACT VIII | R2 Diagnostics, Inc. | Dec 19, 2011 | SESE |
| K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | Jul 8, 2011 | SESE |
| K050661 | HEMOSIL FACTOR II DEFICIENT PLASMA | Instrumentation Laboratory CO | May 2, 2005 | SESE |
| K043459 | HEMOSIL FACTOR XII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 9, 2005 | SESE |
| K040362 | DIAPHARMA FACTOR X KIT | Diapharma Group, Inc. | Jul 12, 2004 | SESE |
| K034007 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 13, 2004 | SESE |
| K031829 | HEMOSIL FACTOR IX DEFICIENT PLASMA | Instrumentation Laboratory CO | Jul 31, 2003 | SESE |
| K031122 | HEMOSIL FACTOR X DEFICIENT PLASMA | Instrumentation Laboratory CO | May 19, 2003 | SESE |
| K030287 | HEMOSIL FACTOR XI DEFICIENT PLASMA | Instrumentation Laboratory CO | Mar 19, 2003 | SESE |
| K024082 | HEMOSIL FACTOR VII DEFICIENT PLASMA | Instrumentation Laboratory CO | Feb 12, 2003 | SESE |
| K023839 | HEMOSIL FACTOR V DEFICIENT PLASMA | Instrumentation Laboratory CO | Jan 14, 2003 | SESE |
| K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Precision Biologic | Jun 7, 1999 | SESE |
| K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | Precision Biologic | Mar 18, 1999 | SESE |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Pacific Hemostasis | Feb 17, 1999 | SESE |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Precision Biologicals, Inc. | Jan 13, 1999 | SESE |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Precision Biologicals, Inc. | Jan 13, 1999 | SESE |
| K981709 | COAGULATION FACTOR V DEFICIENT PLASMA | Dade Behring, Inc. | Oct 13, 1998 | SESE |
Top Applicants
- Instrumentation Laboratory CO — 10 clearances
- Medical Diagnostic Technologies, Inc. — 10 clearances
- American Bioproducts Co. — 9 clearances
- Sigma Chemical Co. — 8 clearances
- Precision Biologicals, Inc. — 7 clearances
