510(k) K041502
- Device
- THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
- Applicant
- HAEMOSCOPE CORP.
- 510(k) number
- K041502
- Product code
- JOZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-09-01
- Date received
- 2004-06-07
- Regulation
- 864.5700
- Classification name
- System, Automated Platelet Aggregation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELI COHEN
- Address
- 5693 W. Howard Niles IL US 60714 60714
FDA Registration Numbers#
- 3003455467
- 1000487132
- 3017875469
- 3005269352
- 2518152
- 3003601075
- 8020030
- 3005739529
- 3016571810
- 1618982
- 3002721930
- 1219343
- 3016579901
- 9610806
- 1217183
- 3019849102
- 3002807408
Source Documents#
Other 510(k) Records For Product Code JOZ #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary