Panels › Hematology › Product code GJT · Class 2
Plasma, Coagulation Factor Deficient
Regulation 864.7290
0510(k)s in 12 months (79 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in GJT
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 13, 2023 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF Precision Biologic, Inc., CA | GJT |
| Mar 22, 2018 | K180486 | HemosIL Factor XII Deficient Plasma Instrumentation Laboratory CO | GJT |
| Dec 19, 2011 | K102908 | NOFACT IX R2 Diagnostics, Inc. | GJT |
| Dec 19, 2011 | K102851 | NOFACT VIII R2 Diagnostics, Inc. | GJT |
| Jul 8, 2011 | K110237 | HEMOSIL FACTOR VIII DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| May 2, 2005 | K050661 | HEMOSIL FACTOR II DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Feb 9, 2005 | K043459 | HEMOSIL FACTOR XII DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Jul 12, 2004 | K040362 | DIAPHARMA FACTOR X KIT Diapharma Group, Inc. | GJT |
| Feb 13, 2004 | K034007 | HEMOSIL FACTOR VIII DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Jul 31, 2003 | K031829 | HEMOSIL FACTOR IX DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| May 19, 2003 | K031122 | HEMOSIL FACTOR X DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Mar 19, 2003 | K030287 | HEMOSIL FACTOR XI DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Feb 12, 2003 | K024082 | HEMOSIL FACTOR VII DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Jan 14, 2003 | K023839 | HEMOSIL FACTOR V DEFICIENT PLASMA Instrumentation Laboratory CO | GJT |
| Jun 7, 1999 | K990814 | CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15 Precision Biologic, CA | GJT |
| Mar 18, 1999 | K990296 | CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML) Precision Biologic, CA | GJT |
| Feb 17, 1999 | K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA Pacific Hemostasis | GJT |
| Jan 13, 1999 | K981174 | CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML) Precision Biologicals, Inc., CA | GJT |
| Jan 13, 1999 | K981173 | CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) Precision Biologicals, Inc., CA | GJT |
| Oct 13, 1998 | K981709 | COAGULATION FACTOR V DEFICIENT PLASMA Dade Behring, Inc. | GJT |
| Aug 13, 1997 | K972627 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) Pacific Hemostasis | GJT |
| Jul 22, 1997 | K971223 | CRYO CHECK FACTOR V DEFICIENT PLASMA Precision Biologicals, Inc., CA | GJT |
| Jul 18, 1997 | K971227 | CRYO CHECK FACTOR X DEFICIENT PLASMA Precision Biologicals, Inc., CA | GJT |
| Jul 18, 1997 | K971226 | CRYO CHECK FACTOR IX DEFICIENT PLASMA Precision Biologicals, Inc., CA | GJT |
| Jul 17, 1997 | K971225 | CRYO CHECK FACTOR VIII DEFICIENT PLASMA Precision Biologicals, Inc., CA | GJT |
| Jul 17, 1997 | K971224 | CRYO CHECK FACTOR VII DEFICIENT PLASMA Precision Biologicals, Inc., CA | GJT |
| Jul 14, 1997 | K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) Universal Reagents, Inc. | GJT |
| Apr 25, 1997 | K970607 | UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA Universal Reagents, Inc. | GJT |
| Apr 25, 1997 | K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA Universal Reagents, Inc. | GJT |
| Oct 25, 1996 | K962675 | STA - LIATEST VWF TEST KIT American Bioproducts Co. | GJT |
| Sep 13, 1996 | K962671 | STA-VWF CALIBRATOR KIT American Bioproducts Co. | GJT |
| Oct 20, 1995 | K945857 | PROTEIN C DEFICIENT PLASMA George King Bio-Medical, Inc. | GJT |
| May 19, 1995 | K942050 | HEMOLAB COFAC IX Biomerieux Vitek, Inc. | GJT |
| May 19, 1995 | K942049 | BIOMERIEUX HEMOLAB COFAC II Biomerieux Vitek, Inc. | GJT |
| Jan 17, 1995 | K935851 | BIOMERIEUX HEMOLAB COFAC X Biomerieux Vitek, Inc. | GJT |
| Jan 17, 1995 | K935850 | BIOMERIEUX HEMOLAB COFAC VII Biomerieux Vitek, Inc. | GJT |
| Mar 15, 1994 | K935057 | FACTOR VIII DEFICIENT PLASMA Sigma Diagnostics, Inc. | GJT |
| Mar 7, 1994 | K935058 | FACTOR Sigma Diagnostics, Inc. | GJT |
| Mar 7, 1994 | K935056 | FACTOR VII DEFICIENT PLASMA Sigma Diagnostics, Inc. | GJT |
| Mar 7, 1994 | K935054 | FACTOR X DEFICIENT PLASMA Sigma Diagnostics, Inc. | GJT |
| Mar 1, 1994 | K934606 | STAGO FACTOR II-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Mar 1, 1994 | K934605 | STAGO FACTOR V-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Nov 15, 1993 | K933432 | STAGO FACTOR IX-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933444 | STAGO FACTOR XI-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933441 | STAGO FACTOR X-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933440 | STAGO FACTOR VII-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Oct 27, 1993 | K933438 | STAGO FACTOR XII-DEFICIENT PLASMA American Bioproducts Co. | GJT |
| Sep 15, 1993 | K933010 | BIOMERIEUX HEMOLAB COFAC VIII Biomerieux Vitek, Inc. | GJT |
| Jun 8, 1993 | K924400 | CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA Behring Diagnostics, Inc. | GJT |
| May 21, 1993 | K924396 | CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA Behring Diagnostics, Inc. | GJT |
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