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510(k) K181777

Device
AggreGuide A-100 ADP
Applicant
Aggredyne, Inc.
510(k) number
K181777
Product code
JOZ  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-29
Date received
2018-07-03
Regulation
864.5700
Classification name
System, Automated Platelet Aggregation
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Phillip Speros
Address
10530 Rockely Rd., Suite 150 Houston TX US 77099 77099

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JOZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K191364T-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 01Fujimori Kogyo, Co., Ltd.2020-02-14
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc.2017-04-05
K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.2016-12-02
K141427ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTESTAccumetrics, Inc.2015-07-24
K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYCoramed Technologies, LLC2015-01-03
K122162AGGREGUIDEAggredyne, Inc.2013-12-20
K103555MULTIPLATE 5.0 AGGREGOMETERVerum Diagnostica GmbH2012-07-27
K060489DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTSDade Behring, Inc.2006-07-21
K050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700Chrono-Log Corp.2005-10-14
K051231VERIFYNOW-P2Y12 ASSAYAccumetrics, Inc.2005-08-05
K042423VERIFYNOW-ASPIRIN ASSAYAccumetrics, Inc.2004-10-06
K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYHaemoscope Corp.2004-09-01
K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592AChrono-Log Corp.2004-04-02
K023761PLATELETWORKS, MODELS PW-A, PW-CHelena Laboratories2003-02-14
K012701ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)Accumetrics, Inc.2002-06-12