System, Automated Platelet Aggregation

FDA product code JOZ · 36 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5700
Review panel: HE
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-01-12 – 2020-02-14

JOZ 2020-02-14

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

Applicant Fujimori Kogyo, Co., Ltd.

K number K191364

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JOZ 2019-03-29

AggreGuide A-100 ADP

Applicant Aggredyne, Inc.

K number K181777

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JOZ 2017-04-05

AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

Applicant Aggredyne, Inc.

K number K163274

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JOZ 2016-12-02

Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel

Applicant Chrono-Log Corp.

K number K161329

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JOZ 2013-12-20

AGGREGUIDE

Applicant Aggredyne, Inc.

K number K122162

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JOZ 2012-07-27

MULTIPLATE 5.0 AGGREGOMETER

Applicant Verum Diagnostica GmbH

K number K103555

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JOZ 2006-07-21

DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS

Applicant Dade Behring, Inc.

K number K060489

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JOZ 2005-10-14

CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700

Applicant Chrono-Log Corp.

K number K050265

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JOZ 2005-08-05

VERIFYNOW-P2Y12 ASSAY

Applicant Accumetrics, Inc.

K number K051231

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JOZ 2004-10-06

VERIFYNOW-ASPIRIN ASSAY

Applicant Accumetrics, Inc.

K number K042423

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JOZ 2004-09-01

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

Applicant Haemoscope Corp.

K number K041502

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JOZ 2004-04-02

CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A

Applicant Chrono-Log Corp.

K number K032951

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JOZ 2003-02-14

PLATELETWORKS, MODELS PW-A, PW-C

Applicant Helena Laboratories

K number K023761

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JOZ 2002-06-12

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

Applicant Accumetrics, Inc.

K number K012701

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JOZ 2002-05-16

MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)

Applicant Accumetrics, Inc.

K number K013596

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JOZ 2001-10-16

ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)

Applicant Accumetrics, Inc.

K number K011337

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JOZ 2001-09-28

PLATELETWORKS

Applicant Helena Laboratories

K number K012723

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JOZ 2001-06-21

DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP

Applicant Dade Behring, Inc.

K number K002885

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JOZ 1999-12-20

ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM

Applicant Accumetrics, Inc.

K number K992531

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JOZ 1999-12-01

PLATELETWORKS

Applicant Array Medical, Inc.

K number K990398

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JOZ 1997-11-17

DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/

Applicant Dade Intl., Inc.

K number K970505

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JOZ 1996-10-22

CHRONO-LOG WHOLE BLOOD AGGREGOMETER (WBA) 591/592

Applicant Chrono-Log Corp.

K number K962426

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JOZ 1996-01-24

CENTOCOR AGGRESTAT, COLLAGEN REAGENT, CONTROL REAGENT

Applicant Centocor, Inc.

K number K954997

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JOZ 1994-10-13

AGGRO/LINK VW COFACTOR SOFTWARE

Applicant Chrono-Log Corp.

K number K940792

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JOZ 1986-07-31

BLOOD PLATELET ASSAY METHOD & APPARATUS

Applicant Bellhouse Medical, Inc.

K number K862302

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JOZ 1985-07-23

MONITOR IV PLUS

Applicant Helena Laboratories

K number K851669

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JOZ 1980-03-25

HELENA RISTOCETIN

Applicant Helena Laboratories

K number K800432

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JOZ 1980-02-05

PLATELET AGGREGATION REAGENTS

Applicant Pacific Hemostasis

K number K800146

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JOZ 1979-09-17

ELVI 840 AGGREGOMETER

Applicant Volu Sol Medical Industries

K number K791577

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JOZ 1979-05-03

BETA/PAK

Applicant Bio/Data Corp.

K number K790769

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JOZ 1978-12-07

COLLAGENREAGENT HORM

Applicant Hormon-Chemie Munchem Gmch

K number K781693

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JOZ 1978-11-22

REAGENT, FIREFLY #395

Applicant Chrono-Log Corp.

K number K781807

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JOZ 1978-03-30

SOLUBLE COLLAGEN

Applicant General Diagnostics

K number K780285

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JOZ 1978-03-02

PLATELET AGGREGATING REAGENTS

Applicant Dade, Baxter Travenol Diagnostics, Inc.

K number K780047

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JOZ 1977-03-21

THROMBO-CETIN (RISTOCETIN)

Applicant Bay Area Hema. Onco. Clinic. & Res. L

K number K770395

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JOZ 1977-01-12

AGGRECETIN

Applicant Bio/Data Corp.

K number K760893

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