Product code GJT
- Device name
- Plasma, Coagulation Factor Deficient
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7290
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023-09-13 |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | 2018-03-22 |
| K102851 | NOFACT VIII | R2 Diagnostics, Inc. | 2011-12-19 |
| K102908 | NOFACT IX | R2 Diagnostics, Inc. | 2011-12-19 |
| K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2011-07-08 |
| K050661 | HEMOSIL FACTOR II DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-05-02 |
| K043459 | HEMOSIL FACTOR XII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-02-09 |
| K040362 | DIAPHARMA FACTOR X KIT | Diapharma Group, Inc. | 2004-07-12 |
| K034007 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2004-02-13 |
| K031829 | HEMOSIL FACTOR IX DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-07-31 |
| K031122 | HEMOSIL FACTOR X DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-05-19 |
| K030287 | HEMOSIL FACTOR XI DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-03-19 |
| K024082 | HEMOSIL FACTOR VII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-02-12 |
| K023839 | HEMOSIL FACTOR V DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-01-14 |
| K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Precision Biologic | 1999-06-07 |
| K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | Precision Biologic | 1999-03-18 |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Pacific Hemostasis | 1999-02-17 |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Precision Biologicals, Inc. | 1999-01-13 |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Precision Biologicals, Inc. | 1999-01-13 |
| K981709 | COAGULATION FACTOR V DEFICIENT PLASMA | Dade Behring, Inc. | 1998-10-13 |
| K972627 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) | Pacific Hemostasis | 1997-08-13 |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-22 |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-18 |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-18 |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-17 |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-17 |
| K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) | Universal Reagents, Inc. | 1997-07-14 |
| K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 |
| K970607 | UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 |
| K962675 | STA - LIATEST VWF TEST KIT | American Bioproducts Co. | 1996-10-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00842768018848 | Coagulation Factor VII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018831 | Coagulation Factor VIII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018855 | Coagulation Factor II Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639598 | Coagulation Factor X Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414639604 | Coagulation Factor XI Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640587 | Coagulation Factor IX Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640679 | Coagulation Factor XII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640686 | Coagulation Factor II Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018862 | Coagulation Factor XII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640761 | Coagulation Factor VIII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00630414640792 | Coagulation Factor VII Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018824 | Coagulation Factor IX Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018879 | Coagulation Factor XI Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018817 | Coagulation Factor X Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-03-25 |
| 00842768018886 | Coagulation Factor V Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-02-19 |
| 00630414640754 | Coagulation Factor V Deficient Plasma | Siemens Healthcare Diagnostics Products GmbH | 2024-02-19 |
| 00843876000589 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | 2023-09-25 |
| 00843876000572 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | 2023-09-25 |
| 00843876010557 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | 2023-09-25 |
| 00843876010564 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic Inc | 2023-09-25 |
| 00815696021310 | George King Factor VIII Deficient Plasma | GEORGE KING BIO-MEDICAL, INC | 2022-03-03 |
| 10859394006160 | NoFact IX | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 10859394006153 | NoFact VIII | R 2 DIAGNOSTICS, INC. | 2016-11-15 |
| 08426950478553 | HemosIL Factor IX Deficient Plasma (10 X 1 mL) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950484738 | HemosIL Factor II Deficient Plasma (10 X 1 mL) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950491385 | HemosIL Factor X Deficient Plasma (10 X 1 mL) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950580690 | HemosIL Factor VIII Deficient Plasma | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 08426950478560 | HemosIL Factor VIII Deficient Plasma (10 X 1 mL) | INSTRUMENTATION LABORATORY COMPANY | 2016-09-23 |
| 13607450007456 | STA® - Deficient II | DIAGNOSTICA STAGO | 2016-09-15 |
| 13607450007449 | STA® - Deficient V | DIAGNOSTICA STAGO | 2016-09-15 |