JOZ · Class II · 21 CFR 864.5700

FDA Product Code JOZ: System, Automated Platelet Aggregation

Leading manufacturers include Chrono-Log Corp., Helena Laboratories and Accumetrics, Inc..

38
Total
38
Cleared
164d
Avg days
1977
Since

FDA 510(k) Cleared System, Automated Platelet Aggregation Devices (Product Code JOZ)

38 devices
1–24 of 38
Cleared Feb 14, 2020
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.
Hematology · 268d
Cleared Mar 29, 2019
AggreGuide A-100 ADP
K181777
Aggredyne, Inc.
Hematology · 269d
Cleared Apr 05, 2017
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
K163274
Aggredyne, Inc.
Hematology · 135d
Cleared Dec 02, 2016
Chrono-log Platelet Aggregometer, 4 channel
K161329
Chrono-Log Corp.
Hematology · 204d
Cleared Jul 24, 2015
ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST
K141427
Accumetrics, Inc.
Hematology · 420d
Cleared Jan 03, 2015
CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAY
K140893
Coramed Technologies, LLC
Hematology · 270d
Cleared Dec 20, 2013
AGGREGUIDE
K122162
Aggredyne, Inc.
Hematology · 518d
Cleared Jul 27, 2012
MULTIPLATE 5.0 AGGREGOMETER
K103555
Verum Diagnostica GmbH
Hematology · 602d
Cleared Jul 21, 2006
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489
Dade Behring, Inc.
Hematology · 147d
Cleared Oct 14, 2005
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265
Chrono-Log Corp.
Hematology · 252d
Cleared Aug 05, 2005
VERIFYNOW-P2Y12 ASSAY
K051231
Accumetrics, Inc.
Hematology · 84d
Cleared Oct 06, 2004
VERIFYNOW-ASPIRIN ASSAY
K042423
Accumetrics, Inc.
Hematology · 29d
Cleared Sep 01, 2004
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
K041502
Haemoscope Corp.
Hematology · 86d
Cleared Apr 02, 2004
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
K032951
Chrono-Log Corp.
Hematology · 193d
Cleared Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
K023761
Helena Laboratories
Hematology · 98d
Cleared Sep 28, 2001
PLATELETWORKS
K012723
Helena Laboratories
Hematology · 44d
Cleared Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885
Dade Behring, Inc.
Hematology · 279d
Cleared Dec 20, 1999
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
K992531
Accumetrics, Inc.
Hematology · 145d
Cleared Dec 01, 1999
PLATELETWORKS
K990398
Array Medical, Inc.
Hematology · 295d
Cleared Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
K970505
Dade Intl., Inc.
Hematology · 280d
Cleared Oct 22, 1996
CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592
K962426
Chrono-Log Corp.
Hematology · 120d
Cleared Jan 24, 1996
CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT
K954997
Centocor, Inc.
Hematology · 84d
Cleared Oct 13, 1994
AGGRO/LINK VW COFACTOR SOFTWARE
K940792
Chrono-Log Corp.
Hematology · 233d
Cleared Jul 23, 1985
MONITOR IV PLUS
K851669
Helena Laboratories
Hematology · 91d

About Product Code JOZ - Regulatory Context