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Panels › Hematology › Product code JOZ · Class 2

System, Automated Platelet Aggregation

Regulation 864.5700

0510(k)s in 12 months (38 all time)
1recalls in 12 months (11 all time)
10recalls that name a 510(k)
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Top companies in JOZ

Company510(k)sRecalls
Accumetrics, Inc.77
Chrono-Log Corp.60
Aggredyne, Inc.31
Helena Laboratories40
Accriva Diagnostics, Inc.03
Bio/Data Corp.20
Dade Behring, Inc.20
Array Medical, Inc.10
Bay Area Hema. Onco. Clinic. & Res. L10
Bellhouse Medical, Inc.10
Decided510(k)Device and applicantCode
Feb 14, 2020K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01,
Fujimori Kogyo, Co., Ltd., JP
JOZ
Mar 29, 2019K181777AggreGuide A-100 ADP
Aggredyne, Inc.
JOZ
Apr 5, 2017K163274AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
Aggredyne, Inc.
JOZ
Dec 2, 2016K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel
Chrono-Log Corp.
JOZ
Jul 24, 2015K141427ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
Accumetrics, Inc.
JOZ
Jan 3, 2015K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
Coramed Technologies, LLC
JOZ
Dec 20, 2013K122162AGGREGUIDE
Aggredyne, Inc.
JOZ
Jul 27, 2012K103555MULTIPLATE 5.0 AGGREGOMETER
Verum Diagnostica GmbH, DE
JOZ
Jul 21, 2006K060489DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
Dade Behring, Inc.
JOZ
Oct 14, 2005K050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
Chrono-Log Corp.
JOZ
Aug 5, 2005K051231VERIFYNOW-P2Y12 ASSAY
Accumetrics, Inc.
JOZ
Oct 6, 2004K042423VERIFYNOW-ASPIRIN ASSAY
Accumetrics, Inc.
JOZ
Sep 1, 2004K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
Haemoscope Corp.
JOZ
Apr 2, 2004K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
Chrono-Log Corp.
JOZ
Feb 14, 2003K023761PLATELETWORKS, MODELS PW-A, PW-C
Helena Laboratories
JOZ
Jun 12, 2002K012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
Accumetrics, Inc.
JOZ
May 16, 2002K013596MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
Accumetrics, Inc.
JOZ
Oct 16, 2001K011337ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
Accumetrics, Inc.
JOZ
Sep 28, 2001K012723PLATELETWORKS
Helena Laboratories
JOZ
Jun 21, 2001K002885DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
Dade Behring, Inc.
JOZ
Dec 20, 1999K992531ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
Accumetrics, Inc.
JOZ
Dec 1, 1999K990398PLATELETWORKS
Array Medical, Inc.
JOZ
Nov 17, 1997K970505DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
Dade Intl., Inc.
JOZ
Oct 22, 1996K962426CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
Chrono-Log Corp.
JOZ
Jan 24, 1996K954997CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
Centocor, Inc.
JOZ
Oct 13, 1994K940792AGGRO/LINK VW COFACTOR SOFTWARE
Chrono-Log Corp.
JOZ
Jul 31, 1986K862302BLOOD PLATELET ASSAY METHOD & APPARATUS
Bellhouse Medical, Inc.
JOZ
Jul 23, 1985K851669MONITOR IV PLUS
Helena Laboratories
JOZ
Mar 25, 1980K800432HELENA RISTOCETIN
Helena Laboratories
JOZ
Feb 5, 1980K800146PLATELET AGGREGATION REAGENTS
Pacific Hemostasis
JOZ
Sep 17, 1979K791577ELVI 840 AGGREGOMETER
Volu Sol Medical Industries
JOZ
May 3, 1979K790769BETA/PAK
Bio/Data Corp.
JOZ
Dec 7, 1978K781693COLLAGENREAGENT HORM
Hormon-Chemie Munchem Gmch
JOZ
Nov 22, 1978K781807REAGENT, FIREFLY #395
Chrono-Log Corp.
JOZ
Mar 30, 1978K780285SOLUBLE COLLAGEN
General Diagnostics
JOZ
Mar 2, 1978K780047PLATELET AGGREGATING REAGENTS
Dade, Baxter Travenol Diagnostics, Inc.
JOZ
Mar 21, 1977K770395THROMBO-CETIN (RISTOCETIN)
Bay Area Hema. Onco. Clinic. & Res. L
JOZ
Jan 12, 1977K760893AGGRECETIN
Bio/Data Corp.
JOZ

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