FDA Product Code
FDA Product Code JOZ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5700
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Traditional | PDF ↗ |
| K181777 | AggreGuide A-100 ADP | Aggredyne, Inc. | 2019-03-29 | Traditional | PDF ↗ |
| K163274 | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument | Aggredyne, Inc. | 2017-04-05 | Special | PDF ↗ |
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel | Chrono-Log Corp. | 2016-12-02 | Special | PDF ↗ |
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST | Accumetrics, Inc. | 2015-07-24 | Traditional | PDF ↗ |
| K140893 | CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY | Coramed Technologies, LLC | 2015-01-03 | Traditional | PDF ↗ |
| K122162 | AGGREGUIDE | Aggredyne, Inc. | 2013-12-20 | Traditional | PDF ↗ |
| K103555 | MULTIPLATE 5.0 AGGREGOMETER | Verum Diagnostica GmbH | 2012-07-27 | Traditional | PDF ↗ |
| K060489 | DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS | Dade Behring, Inc. | 2006-07-21 | Traditional | PDF ↗ |
| K050265 | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 | Chrono-Log Corp. | 2005-10-14 | Traditional | PDF ↗ |
| K051231 | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | 2005-08-05 | Traditional | PDF ↗ |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | 2004-10-06 | Special | PDF ↗ |
| K041502 | THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY | Haemoscope Corp. | 2004-09-01 | Traditional | PDF ↗ |
| K032951 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A | Chrono-Log Corp. | 2004-04-02 | Traditional | PDF ↗ |
| K023761 | PLATELETWORKS, MODELS PW-A, PW-C | Helena Laboratories | 2003-02-14 | Traditional | PDF ↗ |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) | Accumetrics, Inc. | 2002-06-12 | Traditional | PDF ↗ |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) | Accumetrics, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | 2001-10-16 | Traditional | PDF ↗ |
| K012723 | PLATELETWORKS | Helena Laboratories | 2001-09-28 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM | Accumetrics, Inc. | 1999-12-20 | Traditional | PDF ↗ |
| K990398 | PLATELETWORKS | Array Medical, Inc. | 1999-12-01 | Traditional | PDF ↗ |
| K970505 | DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ | Dade Intl., Inc. | 1997-11-17 | Traditional | PDF ↗ |
| K962426 | CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 | Chrono-Log Corp. | 1996-10-22 | Traditional | PDF ↗ |
| K954997 | CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT | Centocor, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K940792 | AGGRO/LINK VW COFACTOR SOFTWARE | Chrono-Log Corp. | 1994-10-13 | Traditional | PDF ↗ |
| K862302 | BLOOD PLATELET ASSAY METHOD & APPARATUS | Bellhouse Medical, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K851669 | MONITOR IV PLUS | Helena Laboratories | 1985-07-23 | Traditional | PDF ↗ |
| K800432 | HELENA RISTOCETIN | Helena Laboratories | 1980-03-25 | Traditional | PDF ↗ |
| K800146 | PLATELET AGGREGATION REAGENTS | Pacific Hemostasis | 1980-02-05 | Traditional | PDF ↗ |
| K791577 | ELVI 840 AGGREGOMETER | Volu Sol Medical Industries | 1979-09-17 | Traditional | PDF ↗ |
| K790769 | BETA/PAK | Bio/Data Corp. | 1979-05-03 | Traditional | PDF ↗ |
| K781693 | COLLAGENREAGENT HORM | Hormon-Chemie Munchem Gmch | 1978-12-07 | Traditional | PDF ↗ |
| K781807 | REAGENT, FIREFLY #395 | Chrono-Log Corp. | 1978-11-22 | Traditional | PDF ↗ |
| K780285 | SOLUBLE COLLAGEN | General Diagnostics | 1978-03-30 | Traditional | PDF ↗ |
| K780047 | PLATELET AGGREGATING REAGENTS | Dade, Baxter Travenol Diagnostics, Inc. | 1978-03-02 | Traditional | PDF ↗ |
| K770395 | THROMBO-CETIN (RISTOCETIN) | Bay Area Hema. Onco. Clinic. & Res. L | 1977-03-21 | Traditional | PDF ↗ |
| K760893 | AGGRECETIN | Bio/Data Corp. | 1977-01-12 | Traditional | PDF ↗ |
Product code JOZ · Class II · Hematology. Data: openFDA.