Product code JOZ
- Device name
- System, Automated Platelet Aggregation
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5700
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191364 | 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 | Fujimori Kogyo, Co., Ltd. | 2020-02-14 |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019-03-29 |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | 2017-04-05 |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | Chrono-Log Corp. | 2016-12-02 |
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | Accumetrics, Inc. | 2015-07-24 |
| K140893 | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | Coramed Technologies, LLC | 2015-01-03 |
| K122162 | AGGREGUIDE | Aggredyne, Inc. | 2013-12-20 |
| K103555 | MULTIPLATE 5.0 AGGREGOMETER | Verum Diagnostica GmbH | 2012-07-27 |
| K060489 | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | Dade Behring, Inc. | 2006-07-21 |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | 2005-10-14 |
| K051231 | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | 2005-08-05 |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | 2004-10-06 |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | 2004-09-01 |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | 2004-04-02 |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Helena Laboratories | 2003-02-14 |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | Accumetrics, Inc. | 2002-06-12 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | Accumetrics, Inc. | 2002-05-16 |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | 2001-10-16 |
| K012723 | PLATELETWORKS | Helena Laboratories | 2001-09-28 |
| K002885 | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP | Dade Behring, Inc. | 2001-06-21 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | Accumetrics, Inc. | 1999-12-20 |
| K990398 | PLATELETWORKS | Array Medical, Inc. | 1999-12-01 |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | Dade Intl., Inc. | 1997-11-17 |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | Chrono-Log Corp. | 1996-10-22 |
| K954997 | CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT | Centocor, Inc. | 1996-01-24 |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | Chrono-Log Corp. | 1994-10-13 |
| K862302 | BLOOD PLATELET ASSAY METHOD & APPARATUS | Bellhouse Medical, Inc. | 1986-07-31 |
| K851669 | MONITOR IV PLUS | Helena Laboratories | 1985-07-23 |
| K800432 | HELENA RISTOCETIN | Helena Laboratories | 1980-03-25 |
| K800146 | PLATELET AGGREGATION REAGENTS | Pacific Hemostasis | 1980-02-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 14589448510102 | BAPA tube | ZACROS CORPORATION | 2024-12-12 |
| 14589448510096 | PL Chip Reservoir Set | ZACROS CORPORATION | 2024-12-12 |
| 14589448510089 | PL Chip | ZACROS CORPORATION | 2024-12-12 |
| 04589448510051 | BAPA tube for T-TAS 01 | ZACROS CORPORATION | 2024-12-12 |
| 04589448510044 | PL Chip Reservoir Set for T-TAS 01 | ZACROS CORPORATION | 2024-12-12 |
| 04589448510037 | PL Chip for T-TAS 01 | ZACROS CORPORATION | 2024-12-12 |
| 04589448510105 | BAPA tube | ZACROS CORPORATION | 2024-12-12 |
| 04589448510099 | PL Chip Reservoir Set | ZACROS CORPORATION | 2024-12-12 |
| 04589448510082 | PL Chip | ZACROS CORPORATION | 2024-12-12 |
| 04589448510013 | T-TAS 01 Total Thrombus Formation Analysis System | ZACROS CORPORATION | 2024-12-06 |
| G0561076501 | AGG/PAK 5 Combo Kit | Bio/Data Corporation | 2024-10-01 |
| 00811476011670 | CHRONO-LOG | CHRONO-LOG CORP | 2023-06-21 |
| 00811476011045 | CHRONO-LOG | CHRONO-LOG CORP | 2023-06-21 |
| 00856893004010 | AggreDYNE AA Assay | AGGREDYNE, INC. | 2019-01-01 |
| 00856893004065 | Aggreguide | AGGREDYNE, INC. | 2019-01-01 |
| 10812747018302 | TEG6s HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-08-18 |
| 10812747018340 | TEG6S HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-07-17 |
| 10812747018296 | TEG6s HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-07-17 |
| 10812747018371 | Hemostasis System | HAEMONETICS CORPORATION | 2017-07-11 |
| 20812747018323 | TEG6s HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-04-25 |
| 10812747018319 | TEG6s HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-04-25 |
| 10812747018074 | TEG HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-03-13 |
| 10812747018067 | TEG HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-03-13 |
| 10812747018050 | TEG HEMOSTASIS SYSTEM | HAEMONETICS CORPORATION | 2017-03-13 |
| M52551990 | Helena Ristocetin | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558620 | Plateletworks Collagen Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558600 | Plateletworks ADP Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558540 | Plateletworks Combo-10 Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558520 | Plateletworks Combo-25 Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52558500 | Plateletworks Combo-15 Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |