JOZ — System, Automated Platelet Aggregation Class II
FDA product code JOZ covers "System, Automated Platelet Aggregation", a Class II medical device regulated under 21 CFR 864.5700. Submissions are reviewed by the Hematology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JOZ
- Device Class
- Class II
- Regulation Number
- 864.5700
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191364 | fujimori kogyo, co | T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS | February 14, 2020 |
| K181777 | aggredyne | AggreGuide A-100 ADP | March 29, 2019 |
| K163274 | aggredyne | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | April 5, 2017 |
| K161329 | chrono-log | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 | December 2, 2016 |
| K141427 | accumetrics | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | July 24, 2015 |
| K140893 | coramed technologies | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | January 3, 2015 |
| K122162 | aggredyne | AGGREGUIDE | December 20, 2013 |
| K103555 | verum diagnostica | MULTIPLATE 5.0 AGGREGOMETER | July 27, 2012 |
| K060489 | dade behring | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | July 21, 2006 |
| K050265 | chrono-log | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | October 14, 2005 |
| K051231 | accumetrics | VERIFYNOW-P2Y12 ASSAY | August 5, 2005 |
| K042423 | accumetrics | VERIFYNOW-ASPIRIN ASSAY | October 6, 2004 |
| K041502 | haemoscope | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | September 1, 2004 |
| K032951 | chrono-log | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | April 2, 2004 |
| K023761 | helena laboratories | PLATELETWORKS, MODELS PW-A, PW-C | February 14, 2003 |
| K012701 | accumetrics | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | June 12, 2002 |
| K013596 | accumetrics | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | May 16, 2002 |
| K011337 | accumetrics | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | October 16, 2001 |
| K012723 | helena laboratories | PLATELETWORKS | September 28, 2001 |
| K002885 | dade behring | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE | June 21, 2001 |