FDA Product Code
FDA Product Code GJT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7290
510(k) Clearances — 79 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023-09-13 | Traditional | PDF ↗ |
| K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | 2018-03-22 | Special | PDF ↗ |
| K102908 | NOFACT IX | R2 Diagnostics, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| K102851 | NOFACT VIII | R2 Diagnostics, Inc. | 2011-12-19 | Traditional | PDF ↗ |
| K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2011-07-08 | Traditional | PDF ↗ |
| K050661 | HEMOSIL FACTOR II DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-05-02 | Traditional | PDF ↗ |
| K043459 | HEMOSIL FACTOR XII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2005-02-09 | Traditional | PDF ↗ |
| K040362 | DIAPHARMA FACTOR X KIT | Diapharma Group, Inc. | 2004-07-12 | Traditional | PDF ↗ |
| K034007 | HEMOSIL FACTOR VIII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2004-02-13 | Traditional | PDF ↗ |
| K031829 | HEMOSIL FACTOR IX DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-07-31 | Traditional | PDF ↗ |
| K031122 | HEMOSIL FACTOR X DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-05-19 | Traditional | PDF ↗ |
| K030287 | HEMOSIL FACTOR XI DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-03-19 | Traditional | PDF ↗ |
| K024082 | HEMOSIL FACTOR VII DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-02-12 | Traditional | PDF ↗ |
| K023839 | HEMOSIL FACTOR V DEFICIENT PLASMA | Instrumentation Laboratory CO | 2003-01-14 | Traditional | PDF ↗ |
| K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 | Precision Biologic | 1999-06-07 | Traditional | PDF ↗ |
| K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) | Precision Biologic | 1999-03-18 | Traditional | PDF ↗ |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | Pacific Hemostasis | 1999-02-17 | Traditional | PDF ↗ |
| K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) | Precision Biologicals, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) | Precision Biologicals, Inc. | 1999-01-13 | Traditional | PDF ↗ |
| K981709 | COAGULATION FACTOR V DEFICIENT PLASMA | Dade Behring, Inc. | 1998-10-13 | Traditional | PDF ↗ |
| K972627 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) | Pacific Hemostasis | 1997-08-13 | Traditional | PDF ↗ |
| K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-18 | Traditional | PDF ↗ |
| K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-17 | Traditional | PDF ↗ |
| K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA | Precision Biologicals, Inc. | 1997-07-17 | Traditional | PDF ↗ |
| K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) | Universal Reagents, Inc. | 1997-07-14 | Traditional | PDF ↗ |
| K970607 | UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 | Traditional | PDF ↗ |
| K962675 | STA - LIATEST VWF TEST KIT | American Bioproducts Co. | 1996-10-25 | Traditional | PDF ↗ |
| K962671 | STA-VWF CALIBRATOR KIT | American Bioproducts Co. | 1996-09-13 | Traditional | PDF ↗ |
| K945857 | PROTEIN C DEFICIENT PLASMA | George King Bio-Medical, Inc. | 1995-10-20 | Traditional | PDF ↗ |
| K942049 | BIOMERIEUX HEMOLAB COFAC II | Biomerieux Vitek, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K942050 | HEMOLAB COFAC IX | Biomerieux Vitek, Inc. | 1995-05-19 | Traditional | PDF ↗ |
| K935851 | BIOMERIEUX HEMOLAB COFAC X | Biomerieux Vitek, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K935850 | BIOMERIEUX HEMOLAB COFAC VII | Biomerieux Vitek, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K935057 | FACTOR VIII DEFICIENT PLASMA | Sigma Diagnostics, Inc. | 1994-03-15 | Traditional | PDF ↗ |
| K935058 | FACTOR | Sigma Diagnostics, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K935054 | FACTOR X DEFICIENT PLASMA | Sigma Diagnostics, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K935056 | FACTOR VII DEFICIENT PLASMA | Sigma Diagnostics, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K934605 | STAGO FACTOR V-DEFICIENT PLASMA | American Bioproducts Co. | 1994-03-01 | Traditional | PDF ↗ |
| K934606 | STAGO FACTOR II-DEFICIENT PLASMA | American Bioproducts Co. | 1994-03-01 | Traditional | PDF ↗ |
| K933432 | STAGO FACTOR IX-DEFICIENT PLASMA | American Bioproducts Co. | 1993-11-15 | Traditional | PDF ↗ |
| K933444 | STAGO FACTOR XI-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | Traditional | PDF ↗ |
| K933438 | STAGO FACTOR XII-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | Traditional | PDF ↗ |
| K933441 | STAGO FACTOR X-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | Traditional | PDF ↗ |
| K933440 | STAGO FACTOR VII-DEFICIENT PLASMA | American Bioproducts Co. | 1993-10-27 | Traditional | PDF ↗ |
| K933010 | BIOMERIEUX HEMOLAB COFAC VIII | Biomerieux Vitek, Inc. | 1993-09-15 | Traditional | PDF ↗ |
| K924400 | CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA | Behring Diagnostics, Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K924396 | CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA | Behring Diagnostics, Inc. | 1993-05-21 | Traditional | PDF ↗ |
| K924394 | CLOTTING FACTOR V DEFICIENT PLASMA | Behring Diagnostics, Inc. | 1992-12-01 | Traditional | PDF ↗ |
| K915411 | DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA | Baxter Diagnostics, Inc. | 1992-05-11 | Traditional | PDF ↗ |
| K912679 | DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) | Baxter Healthcare Corp | 1991-09-10 | Traditional | PDF ↗ |
| K902083 | CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE | Helena Laboratories | 1990-06-15 | Traditional | PDF ↗ |
| K901327 | ORTHO CORRECTION REAGENTS | Ortho Diagnostic Systems, Inc. | 1990-05-25 | Traditional | PDF ↗ |
| K900411 | FACTOR XI DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900408 | FACTOR VIII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900406 | FACTOR V DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900410 | FACTOR X DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900412 | FACTOR XII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900409 | FACTOR IX DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900407 | FACTOR VII DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900906 | FACTOR II DEFICIENT PLASMA | Sigma Chemical Co. | 1990-03-06 | Traditional | PDF ↗ |
| K900133 | FACTOR II DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1990-01-25 | Traditional | PDF ↗ |
| K895504 | ABNORMAL REFERENCE PLASMA-IX | Medical Diagnostic Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K895503 | ABNORMAL REFERENCE PLASMA-VIII | Medical Diagnostic Technologies, Inc. | 1989-10-06 | Traditional | PDF ↗ |
| K893523 | FACTOR X DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893525 | FACTOR VIII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893535 | FACTOR VII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893524 | FACTOR IX DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893534 | FACTOR XII DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893533 | FACTOR V DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893536 | FACTOR XI DEFICIENT PLASMA | Medical Diagnostic Technologies, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K883691 | ORTHO FACTOR XI DEFICIENT PLASMA | Ortho Diagnostic Systems, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K883690 | ORTHO FACTOR X DEFICIENT PLASMA | Ortho Diagnostic Systems, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K883688 | ORTHO FACTOR XII DEFICIENT PLASMA | Ortho Diagnostic Systems, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K883692 | ORTHO FACTOR VII DEFICIENT PLASMA | Ortho Diagnostic Systems, Inc. | 1988-11-01 | Traditional | PDF ↗ |
| K880874 | IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN | Baxter Healthcare Corp | 1988-03-17 | Traditional | PDF ↗ |
| K880292 | FACTOR VIII REFERENCE PLASMA | Helena Laboratories | 1988-02-19 | Traditional | PDF ↗ |
Product code GJT · Class II · Hematology. Data: openFDA.