FDA 510(k) Applications for Medical Device Product Code "GGP"
(Test, Qualitative And Quantitative Factor Deficiency)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K952126 | AALTO SCIENTIFIC LTD. | AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II | 02/29/1996 |
| K051054 | AFFINITY BIOLOGICALS INC. | VISULIZE FACTOR IX ANTIGEN KIT | 06/29/2005 |
| K052825 | AFFINITY BIOLOGICALS INC. | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | 01/20/2006 |
| K971519 | AMERICAN BIOPRODUCTS CO. | ASSERACHROM TPA TEST KIT | 08/19/1997 |
| K012386 | AMERICAN DIAGNOSTICA, INC. | ACTICLOT PROTEIN S, MODEL 843L | 09/14/2001 |
| K013168 | AMERICAN DIAGNOSTICA, INC. | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | 03/07/2002 |
| K013492 | AMERICAN DIAGNOSTICA, INC. | IMUBIND TPA ELISA, MODEL 860 | 03/13/2002 |
| K063323 | AMERICAN DIAGNOSTICA, INC. | SPECTROLYSE PAI-1, MODEL 101201 | 08/15/2007 |
| K962968 | BEHRING DIAGNOSTICS, INC. | PROC APC ASSAY, PROC CONTROL PLASMA | 12/13/1996 |
| K972116 | BEHRING DIAGNOSTICS, INC. | VON WILLEBRAND REAGENT | 07/25/1997 |
| K983898 | BIOPOOL INTL., INC. | BIOCLOT APC SENSITIVITY | 01/06/1999 |
| K062530 | BIOSITE INCORPORATED | TRIAGE PROTEIN C TEST | 01/29/2007 |
| K983914 | CORGENIX, INC. | REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT | 12/22/1998 |
| K032139 | CORGENIX, INC. | REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 | 04/05/2004 |
| K971985 | CRESTAT DIAGNOSTICS, INC. | N-ASSAY TIA PLASMINOGEN TEST KIT | 10/20/1997 |
| K002541 | DADE BEHRING, INC. | PROTEIN C REAGENT | 09/26/2000 |
| K022290 | DADE BEHRING, INC. | PROTEIN S AC | 08/27/2002 |
| K000649 | DADE BEHRING, INC. | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | 04/25/2000 |
| K092170 | DIAGNOSTICA STAGO, INC. | STA LIATEST FREE PS | 12/22/2009 |
| K010963 | DIAGNOSTICA STAGO, INC. | STA-LIATEST FREE PROTEIN S TEST KIT | 06/06/2001 |
| K082205 | GENETIC TESTING INSTITUTE | FACTOR VIII ANTIBODY SCREEN | 11/20/2008 |
| K993553 | GENETIC TESTING INSTITUTE | GTI-FVIII INHIBITOR ASSAY | 02/01/2000 |
| K952668 | HELENA LABORATORIES | CHROM Z-F:VIII, CAT. NO. 5241 | 02/09/1996 |
| K952666 | HELENA LABORATORIES | CHROM Z-PROTEIN C, CAT. NO. 5243 | 01/30/1996 |
| K050448 | HORIBA ABX | CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 | 09/23/2005 |
| K050365 | HYPHEN BIOMED | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | 12/27/2005 |
| K002467 | INSTRUMENTATION LABORATORY CO. | COALIZA PROTEIN S-FREE | 10/13/2000 |
| K981038 | INSTRUMENTATION LABORATORY CO. | COAMATIC FACTOR VIII | 04/16/1998 |
| K981817 | INSTRUMENTATION LABORATORY CO. | COAMATIC PLASMIN INHIBITOR | 09/28/1998 |
| K974711 | INSTRUMENTATION LABORATORY CO. | COAMATIC PLASMINOGEN | 05/01/1998 |
| K042576 | INSTRUMENTATION LABORATORY CO. | COATEST SP FVIII | 12/02/2004 |
| K070635 | INSTRUMENTATION LABORATORY CO. | HEMOSIL PROCLOT | 03/29/2007 |
| K053499 | INSTRUMENTATION LABORATORY CO. | HEMOSIL PROS | 01/13/2006 |
| K062430 | INSTRUMENTATION LABORATORY CO. | HEMOSIL PROTEIN C | 09/01/2006 |
| K102164 | INSTRUMENTATION LABORATORY CO. | HEMOSIL PROTEIN S ACTIVITY ASSAY | 03/17/2011 |
| K040843 | INSTRUMENTATION LABORATORY CO. | HEMOSIL VON WILLEBRAND ACTIVITY | 04/30/2004 |
| K133005 | INSTRUMENTATION LABORATORY CO. | HEMOSIL VON WILLEBRAND ACTIVITY ASSAY | 03/13/2014 |
| K200033 | Instrumentation Laboratory Co. | HemosIL von Willebrand Factor Antigen | 08/19/2020 |
| K223402 | Instrumentation Laboratory Co. | HemosIL von Willebrand Factor Antigen | 12/09/2022 |
| K010379 | INSTRUMENTATION LABORATORY CO. | IL TEST FREE PROTEIN S | 04/13/2001 |
| K981696 | INSTRUMENTATION LABORATORY CO. | IL TEST PLASMIN INHIBITOR | 08/27/1998 |
| K981200 | INSTRUMENTATION LABORATORY CO. | IL TEST PLASMINOGEN | 05/26/1998 |
| K011424 | INSTRUMENTATION LABORATORY CO. | IL TEST PROS | 06/25/2001 |
| K980875 | INSTRUMENTATION LABORATORY CO. | IL TEST PROTEIN C | 04/21/1998 |
| K992704 | INSTRUMENTATION LABORATORY CO. | IL TEST VON WILLEBRAND FACTOR | 11/01/1999 |
| K033631 | INSTRUMENTATION LABORATORY CO. | MODIFICATION TO COATEST FACTOR VIII | 12/15/2003 |
| K955738 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | BIOCLOT PROTEIN S | 02/29/1996 |
| K963106 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | CHROMOLIZE PAI-1 KIT | 11/18/1996 |
| K962489 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | CHROMOLIZE TPA ASSAY KIT | 07/31/1996 |
| K960438 | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. | TINTELIZE PAI-1 KIT | 06/05/1996 |
| K023990 | PRECISION BIOLOGIC | CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 | 03/19/2003 |
| K193204 | Precision BioLogic | Cryocheck Chromogenic Factor VIII | 07/17/2020 |
| K214002 | Precision BioLogic Inc. | CRYOcheck Chromogenic Factor IX | 12/23/2022 |
| K040987 | PRECISION BIOLOGIC INC. | CRYOCHECK CLOT C | 06/18/2004 |
| K043571 | PRECISION BIOLOGIC INC. | CRYOCHECK CLOT S | 03/18/2005 |
| K183440 | Precision BioLogic Inc. | CRYOcheck FVIII Inhibitor Kit | 03/12/2019 |
| K082631 | R2 DIAGNOSTICS, INC. | THROMBO TEK PSE, MODEL 90-480 | 12/17/2008 |
| K983107 | RAMCO LABORATORIES, INC. | VFE | 10/22/1998 |
| K972342 | REAADS MEDICAL PRODUCTS, INC. | REAADS PROTEIN C ANTIGEN TEST KIT | 10/06/1997 |
| K972482 | REAADS MEDICAL PRODUCTS, INC. | REAADS PROTEIN S ANTIGEN TEST KIT | 08/13/1997 |
| K972005 | REAADS MEDICAL PRODUCTS, INC. | REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT | 08/13/1997 |
| K980885 | SHIELD DIAGNOSTICS, LTD. | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | 08/21/1998 |
| K962825 | SHIELD DIAGNOSTICS, LTD. | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | 11/15/1996 |
| K000398 | SHIELD DIAGNOSTICS, LTD. | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | 04/17/2000 |
| K181525 | Siemens Healthcare Diagnostics Products GmbH | INNOVANCE Free PS Ag | 09/07/2018 |
| K220728 | Siemens Healthcare Diagnostics Products GmbH | vWF Ag | 06/02/2023 |
| K951640 | THE BINDING SITE, LTD. | HUMAN PROTEIN S RID TEST KIT | 04/21/1997 |
| K002350 | THE GENETICS INSTITUTE | REFACTO LABORATORY STANDARD | 10/05/2000 |
| K961929 | UNIVERSAL REAGENTS, INC. | FACTOR DEFICIENT PLASMA | 10/10/1996 |
| K972288 | UNIVERSAL REAGENTS, INC. | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) | 07/14/1997 |
| K964270 | UNIVERSAL REAGENTS, INC. | UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA | 12/18/1996 |
| K964459 | UNIVERSAL REAGENTS, INC. | UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA | 12/18/1996 |
| K973143 | UNIVERSAL REAGENTS, INC. | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA | 09/25/1997 |
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