JOZ · System, Automated Platelet Aggregation
Hematology · 21 CFR 864.5700 · Class 2
Overview
| Product Code | JOZ |
|---|---|
| Device Name | System, Automated Platelet Aggregation |
| Regulation | 21 CFR 864.5700 |
| Device Class | Class 2 |
| Review Panel | Hematology |
| 3rd-Party Reviewable | Yes |
Identification
An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Feb 14, 2020 | SESE |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | Mar 29, 2019 | SESE |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | Apr 5, 2017 | SESE |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | Chrono-Log Corp. | Dec 2, 2016 | SESE |
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | Accumetrics, Inc. | Jul 24, 2015 | SESE |
| K140893 | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | Coramed Technologies, LLC | Jan 3, 2015 | SESE |
| K122162 | AGGREGUIDE | Aggredyne, Inc. | Dec 20, 2013 | SESE |
| K103555 | MULTIPLATE 5.0 AGGREGOMETER | Verum Diagnostica GmbH | Jul 27, 2012 | SESE |
| K060489 | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | Dade Behring, Inc. | Jul 21, 2006 | SESE |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | Oct 14, 2005 | SESE |
| K051231 | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | Aug 5, 2005 | SESE |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | Oct 6, 2004 | SESE |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | Sep 1, 2004 | SESE |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | Apr 2, 2004 | SESE |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Helena Laboratories | Feb 14, 2003 | SESE |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | Accumetrics, Inc. | Jun 12, 2002 | SESE |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | Accumetrics, Inc. | May 16, 2002 | SESE |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | Oct 16, 2001 | SESE |
| K012723 | PLATELETWORKS | Helena Laboratories | Sep 28, 2001 | SESE |
| K002885 | DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP | Dade Behring, Inc. | Jun 21, 2001 | SESE |
Top Applicants
- Accumetrics, Inc. — 7 clearances
- Chrono-Log Corp. — 6 clearances
- Helena Laboratories — 4 clearances
- Aggredyne, Inc. — 3 clearances
- Bio/Data Corp. — 2 clearances
