Atlas FDA

JOZ

38 FDA 510(k) clearances · Product code

135 daysmedian time to decision
302 days90th percentile
38clearances measured

FDA profile

Official device name
System, Automated Platelet Aggregation
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5700
Medical specialty
Hematology
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 12 · 2018: 25 · 2022: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
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 (K191364)Fujimori Kogyo, Co., Ltd.2020-02-14
AggreGuide A-100 ADP (K181777)Aggredyne, Inc.2019-03-29
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (K163274)Aggredyne, Inc.2017-04-05
Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel (K161329)Chrono-Log Corp.2016-12-02
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST (K141427)Accumetrics, Inc.2015-07-24
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY (K140893)Coramed Technologies, LLC2015-01-03
AGGREGUIDE (K122162)Aggredyne, Inc.2013-12-20
MULTIPLATE 5.0 AGGREGOMETER (K103555)Verum Diagnostica GmbH2012-07-27
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS (K060489)Dade Behring, Inc.2006-07-21
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 (K050265)Chrono-Log Corp.2005-10-14
VERIFYNOW-P2Y12 ASSAY (K051231)Accumetrics, Inc.2005-08-05
VERIFYNOW-ASPIRIN ASSAY (K042423)Accumetrics, Inc.2004-10-06
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY (K041502)Haemoscope Corp.2004-09-01
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A (K032951)Chrono-Log Corp.2004-04-02
PLATELETWORKS, MODELS PW-A, PW-C (K023761)Helena Laboratories2003-02-14
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA) (K012701)Accumetrics, Inc.2002-06-12
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP) (K013596)Accumetrics, Inc.2002-05-16
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) (K011337)Accumetrics, Inc.2001-10-16
PLATELETWORKS (K012723)Helena Laboratories2001-09-28
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP (K002885)Dade Behring, Inc.2001-06-21
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM (K992531)Accumetrics, Inc.1999-12-20
PLATELETWORKS (K990398)Array Medical, Inc.1999-12-01
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/ (K970505)Dade Intl., Inc.1997-11-17
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592 (K962426)Chrono-Log Corp.1996-10-22
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT (K954997)Centocor, Inc.1996-01-24
AGGRO/LINK VW COFACTOR SOFTWARE (K940792)Chrono-Log Corp.1994-10-13
BLOOD PLATELET ASSAY METHOD & APPARATUS (K862302)Bellhouse Medical, Inc.1986-07-31
MONITOR IV PLUS (K851669)Helena Laboratories1985-07-23
HELENA RISTOCETIN (K800432)Helena Laboratories1980-03-25
PLATELET AGGREGATION REAGENTS (K800146)Pacific Hemostasis1980-02-05
ELVI 840 AGGREGOMETER (K791577)Volu Sol Medical Industries1979-09-17
BETA/PAK (K790769)Bio/Data Corp.1979-05-03
COLLAGENREAGENT HORM (K781693)Hormon-Chemie Munchem Gmch1978-12-07
REAGENT, FIREFLY #395 (K781807)Chrono-Log Corp.1978-11-22
SOLUBLE COLLAGEN (K780285)General Diagnostics1978-03-30
PLATELET AGGREGATING REAGENTS (K780047)Dade, Baxter Travenol Diagnostics, Inc.1978-03-02
THROMBO-CETIN (RISTOCETIN) (K770395)Bay Area Hema. Onco. Clinic. & Res. L1977-03-21
AGGRECETIN (K760893)Bio/Data Corp.1977-01-12

Track JOZ automatically

Every clearance here is in the API, with alerts when new ones post.