JOZ

PLATELETWORKS

Advisory panel: Hematology
Total cleared: 38

Recent clearances under product code JOZ

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
K791577 — ELVI 840 AGGREGOMETER Volu Sol Medical Industries · 1979-09-17
K790769 — BETA/PAK Bio/Data Corp. · 1979-05-03
K781693 — COLLAGENREAGENT HORM Hormon-Chemie Munchem Gmch · 1978-12-07
K781807 — REAGENT, FIREFLY #395 Chrono-Log Corp. · 1978-11-22
K780285 — SOLUBLE COLLAGEN General Diagnostics · 1978-03-30
K780047 — PLATELET AGGREGATING REAGENTS Dade, Baxter Travenol Diagnostics, Inc. · 1978-03-02
K770395 — THROMBO-CETIN (RISTOCETIN) Bay Area Hema. Onco. Clinic. & Res. L · 1977-03-21
K760893 — AGGRECETIN Bio/Data Corp. · 1977-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.