Product Code: JOZ


Products Classified as JOZ

2361System, Automated Platelet AggregationAutomated Platelet Aggregation System.

Total Product Life Cycle (TPLC) Devices

2361System, Automated Platelet AggregationAutomated Platelet Aggregation System.

FDA Consensus Standards

System, Automated Platelet Aggregation [26729]21 CFR §864.5700 🔎

Pre-market Notifications for JOZ

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.
K181777AggreGuide A-100 ADPAggredyne, Inc.
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc.
K161329Chrono-log Platelet Aggregometer, 4 Channel; Chrono-log Platelet Aggregometer, 8 ChannelChrono-log Corp.
K141427ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTESTACCUMETRICS, INC.
K140893CORA (COAGULATION RESONANCE ANALYSIS) SYSTEM WITH PLATELET MAPPING ASSAYCORAMED TECHNOLOGIES, LLC
K122162AGGREGUIDEAGGREDYNE, INC.
K103555MULTIPLATE 5.0 AGGREGOMETERVERUM DIAGNOSTICA GMBH
K060489DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTSDADE BEHRING, INC.
K051231VERIFYNOW-P2Y12 ASSAYACCUMETRICS, INC.
K050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700CHRONO-LOG CORP.
K042423VERIFYNOW-ASPIRIN ASSAYACCUMETRICS, INC.
K041502THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAYHAEMOSCOPE CORP.
K032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592ACHRONO-LOG CORP.
K023761PLATELETWORKS, MODELS PW-A, PW-CHELENA LABORATORIES

Global Unique Device Identification Database

00811476010994System, Automated Platelet Aggregation
00811476010987System, Automated Platelet Aggregation
00811476010499System, Automated Platelet Aggregation
00811476010482System, Automated Platelet Aggregation
00811476010437System, Automated Platelet Aggregation
00811476010420System, Automated Platelet Aggregation
00811476010413System, Automated Platelet Aggregation
00811476010406System, Automated Platelet Aggregation
00811476010390System, Automated Platelet Aggregation
00811476010383System, Automated Platelet Aggregation
00856893004041System, Automated Platelet Aggregation
20856893004014System, Automated Platelet Aggregation
00842768024870SYSTEM, AUTOMATED PLATELET AGGREGATION
00842768003998SYSTEM, AUTOMATED PLATELET AGGREGATION
00842768003691SYSTEM, AUTOMATED PLATELET AGGREGATION

Maude Adverse Events

TEG? HEMOSTASIS ANALYZER SYSTEMHAEMONETICS CORPORATION2020-02-20
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-13
PFA COLLAGEN/EPISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-11
PFA COLLAGEN/EPISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-11
PFA COLLAGEN/EPISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-11
PFA COLLAGEN/EPISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-11
PFA COLLAGEN/EPISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-12-11
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-11-19
INNOVANCE PFA-200 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-05-03
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2019-01-04
VERIFYNOWWERFEN COMPANY/ACCRIVA DIAGNOSTIC, INC.2018-12-28
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-12-14
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-08-31
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
PFA-100 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-07-16
INNOVANCE PFA-200 SYSTEMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2018-06-13
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH2017-03-28
*SYSTEM, AUTOMATED PLATELET AGGREGATIONSIEMENS HEALTHCARE USA2014-09-26
MULTIPLATE ANALYZERROCHE DIAGNOSTICS2013-11-22
VERIFYNOW P2Y12 TEST DEVICEACCUMETRICS2012-06-20
PLAVIX TESTACCUMETRICS2010-11-02
ULTEGRA RPFA-TRAPACCUMETRICS2005-03-11
ULTEGRA RPFA-TRAPACCUMETRICS2000-10-26
ULTEGRA RPFA-TRAPACCUMETRICS2000-10-12
ULTEGRA RPFA-TRAPACCUMETRICS INC.2000-10-10
ULTEGRA RPFA-TRAPACCUMETRICS2000-08-04
ULTEGRA RPFA-TRAPACCUMETRICS2000-07-13
ULTEGRA RPFA-TRAPACCUMETRICS2000-07-07
ULTEGRA RPFA-TRAPACCUMETRICS2000-06-22
ULTEGRA RPFA-TRAPACCUMETRICS2000-06-02
ULTEGRA RPFA-TRAPACCUMETRICS2000-05-03
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