Panels › Hematology › Product code GGP · Class 2
Test, Qualitative And Quantitative Factor Deficiency
Regulation 864.7290
0510(k)s in 12 months (190 all time)
2recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in GGP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2025 | K251440 | CRYOcheck Chromogenic Factor VIII Precision Biologic, Inc., CA | GGP |
| Dec 13, 2023 | K230852 | HemosIL Chromogenic Factor IX Instrumentation Laboratory Company | GGP |
| Jun 2, 2023 | K220728 | vWF Ag Siemens Healthcare Diagnostics Products GmbH, DE | GGP |
| Dec 23, 2022 | K214002 | CRYOcheck Chromogenic Factor IX Precision Biologic, Inc., CA | GGP |
| Dec 9, 2022 | K223402 | HemosIL von Willebrand Factor Antigen Instrumentation Laboratory CO | GGP |
| Aug 19, 2020 | K200033 | HemosIL von Willebrand Factor Antigen Instrumentation Laboratory CO | GGP |
| Jul 17, 2020 | K193204 | Cryocheck Chromogenic Factor VIII Precision Biologic, CA | GGP |
| Mar 12, 2019 | K183440 | CRYOcheck FVIII Inhibitor Kit Precision Biologic, Inc., CA | GGP |
| Sep 7, 2018 | K181525 | INNOVANCE Free PS Ag Siemens Healthcare Diagnostics Products GmbH, DE | GGP |
| Mar 13, 2014 | K133005 | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY Instrumentation Laboratory CO | GGP |
| Mar 17, 2011 | K102164 | HEMOSIL PROTEIN S ACTIVITY ASSAY Instrumentation Laboratory CO | GGP |
| Dec 22, 2009 | K092170 | STA LIATEST FREE PS Diagnostica Stago, Inc. | GGP |
| Dec 17, 2008 | K082631 | THROMBO TEK PSE, MODEL 90-480 R2 Diagnostics, Inc. | GGP |
| Nov 20, 2008 | K082205 | FACTOR VIII ANTIBODY SCREEN Genetic Testing Institute | GGP |
| Aug 15, 2007 | K063323 | SPECTROLYSE PAI-1, MODEL 101201 American Diagnostica, Inc. | GGP |
| Mar 29, 2007 | K070635 | HEMOSIL PROCLOT Instrumentation Laboratory CO | GGP |
| Jan 29, 2007 | K062530 | TRIAGE PROTEIN C TEST Biosite Incorporated | GGP |
| Sep 1, 2006 | K062430 | HEMOSIL PROTEIN C Instrumentation Laboratory CO | GGP |
| Jan 20, 2006 | K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG Affinity Biologicals, Inc., CA | GGP |
| Jan 13, 2006 | K053499 | HEMOSIL PROS Instrumentation Laboratory CO | GGP |
| Dec 27, 2005 | K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 Hyphen Biomed | GGP |
| Sep 23, 2005 | K050448 | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 Horiba Abx, FR | GGP |
| Jun 29, 2005 | K051054 | VISULIZE FACTOR IX ANTIGEN KIT Affinity Biologicals, Inc., CA | GGP |
| Mar 18, 2005 | K043571 | CRYOCHECK CLOT S Precision Biologic, Inc., CA | GGP |
| Dec 2, 2004 | K042576 | COATEST SP FVIII Instrumentation Laboratory CO | GGP |
| Jun 18, 2004 | K040987 | CRYOCHECK CLOT C Precision Biologic, Inc., CA | GGP |
| Apr 30, 2004 | K040843 | HEMOSIL VON WILLEBRAND ACTIVITY Instrumentation Laboratory CO | GGP |
| Apr 5, 2004 | K032139 | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 Corgenix, Inc. | GGP |
| Dec 15, 2003 | K033631 | MODIFICATION TO COATEST FACTOR VIII Instrumentation Laboratory CO | GGP |
| Mar 19, 2003 | K023990 | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 Precision Biologic, CA | GGP |
| Aug 27, 2002 | K022290 | PROTEIN S AC Dade Behring, Inc. | GGP |
| Mar 13, 2002 | K013492 | IMUBIND TPA ELISA, MODEL 860 American Diagnostica, Inc. | GGP |
| Mar 7, 2002 | K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 American Diagnostica, Inc. | GGP |
| Sep 14, 2001 | K012386 | ACTICLOT PROTEIN S, MODEL 843L American Diagnostica, Inc. | GGP |
| Jun 25, 2001 | K011424 | IL TEST PROS Instrumentation Laboratory CO | GGP |
| Jun 6, 2001 | K010963 | STA-LIATEST FREE PROTEIN S TEST KIT Diagnostica Stago, Inc. | GGP |
| Apr 13, 2001 | K010379 | IL TEST FREE PROTEIN S Instrumentation Laboratory CO | GGP |
| Oct 13, 2000 | K002467 | COALIZA PROTEIN S-FREE Instrumentation Laboratory CO | GGP |
| Oct 5, 2000 | K002350 | REFACTO LABORATORY STANDARD The Genetics Institute | GGP |
| Sep 26, 2000 | K002541 | PROTEIN C REAGENT Dade Behring, Inc. | GGP |
| Apr 25, 2000 | K000649 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 Dade Behring, Inc. | GGP |
| Apr 17, 2000 | K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 Shield Diagnostics, Ltd., GB | GGP |
| Feb 1, 2000 | K993553 | GTI-FVIII INHIBITOR ASSAY Genetic Testing Institute | GGP |
| Nov 1, 1999 | K992704 | IL TEST VON WILLEBRAND FACTOR Instrumentation Laboratory CO | GGP |
| Jan 6, 1999 | K983898 | BIOCLOT APC SENSITIVITY Biopool Intl., Inc. | GGP |
| Dec 22, 1998 | K983914 | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT Corgenix, Inc. | GGP |
| Oct 22, 1998 | K983107 | VFE Ramco Laboratories, Inc. | GGP |
| Sep 28, 1998 | K981817 | COAMATIC PLASMIN INHIBITOR Instrumentation Laboratory CO | GGP |
| Aug 27, 1998 | K981696 | IL TEST PLASMIN INHIBITOR Instrumentation Laboratory CO | GGP |
| Aug 21, 1998 | K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY Shield Diagnostics, Ltd., GB | GGP |
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