FDA 510(k) Applications for Medical Device Product Code "JOZ"
(System, Automated Platelet Aggregation)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K141427 | ACCUMETRICS, INC. | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | 07/24/2015 |
| K013596 | ACCUMETRICS, INC. | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | 05/16/2002 |
| K992531 | ACCUMETRICS, INC. | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | 12/20/1999 |
| K012701 | ACCUMETRICS, INC. | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | 06/12/2002 |
| K011337 | ACCUMETRICS, INC. | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | 10/16/2001 |
| K042423 | ACCUMETRICS, INC. | VERIFYNOW-ASPIRIN ASSAY | 10/06/2004 |
| K051231 | ACCUMETRICS, INC. | VERIFYNOW-P2Y12 ASSAY | 08/05/2005 |
| K122162 | AGGREDYNE, INC. | AGGREGUIDE | 12/20/2013 |
| K163274 | Aggredyne, Inc. | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | 04/05/2017 |
| K181777 | Aggredyne, Inc. | AggreGuide A-100 ADP | 03/29/2019 |
| K990398 | ARRAY MEDICAL, INC. | PLATELETWORKS | 12/01/1999 |
| K954997 | CENTOCOR, INC. | CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT | 01/24/1996 |
| K161329 | Chrono-log Corp. | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | 12/02/2016 |
| K962426 | CHRONO-LOG CORP. | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | 10/22/1996 |
| K032951 | CHRONO-LOG CORP. | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | 04/02/2004 |
| K050265 | CHRONO-LOG CORP. | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | 10/14/2005 |
| K140893 | CORAMED TECHNOLOGIES, LLC | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | 01/03/2015 |
| K060489 | DADE BEHRING, INC. | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | 07/21/2006 |
| K002885 | DADE BEHRING, INC. | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP | 06/21/2001 |
| K970505 | DADE INTL., INC. | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | 11/17/1997 |
| K191364 | Fujimori Kogyo Co., Ltd. | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 | 02/14/2020 |
| K041502 | HAEMOSCOPE CORP. | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | 09/01/2004 |
| K012723 | HELENA LABORATORIES | PLATELETWORKS | 09/28/2001 |
| K023761 | HELENA LABORATORIES | PLATELETWORKS, MODELS PW-A, PW-C | 02/14/2003 |
| K103555 | VERUM DIAGNOSTICA GMBH | MULTIPLATE 5.0 AGGREGOMETER | 07/27/2012 |
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