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JOZ — System, Automated Platelet Aggregation Class II

FDA Device Classification

Classification Details

Product Code
JOZ
Device Class
Class II
Regulation Number
864.5700
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K191364fujimori kogyo, coT-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS February 14, 2020
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K161329chrono-logChrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8December 2, 2016
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K140893coramed technologiesCORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYJanuary 3, 2015
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K103555verum diagnosticaMULTIPLATE 5.0 AGGREGOMETERJuly 27, 2012
K060489dade behringDADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTSJuly 21, 2006
K050265chrono-logCHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700October 14, 2005
K051231accumetricsVERIFYNOW-P2Y12 ASSAYAugust 5, 2005
K042423accumetricsVERIFYNOW-ASPIRIN ASSAYOctober 6, 2004
K041502haemoscopeTHROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYSeptember 1, 2004
K032951chrono-logCHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592AApril 2, 2004
K023761helena laboratoriesPLATELETWORKS, MODELS PW-A, PW-CFebruary 14, 2003
K012701accumetricsULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)June 12, 2002
K013596accumetricsMODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)May 16, 2002
K011337accumetricsULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)October 16, 2001
K012723helena laboratoriesPLATELETWORKSSeptember 28, 2001
K002885dade behringDADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINEJune 21, 2001