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TPLC
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Device
system, automated platelet aggregation
Product Code
JOZ
Regulation Number
864.5700
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACCUMETRICS, INC.
SUBSTANTIALLY EQUIVALENT
1
AGGREDYNE, INC.
SUBSTANTIALLY EQUIVALENT
3
CHRONO-LOG CORP.
SUBSTANTIALLY EQUIVALENT
1
CORAMED TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
FUJIMORI KOGYO CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VERUM DIAGNOSTICA GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2017
1
1
2018
25
25
2019
9
9
2020
2
2
2021
2
2
2022
16
16
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
26
26
Low Test Results
20
20
Incorrect, Inadequate or Imprecise Result or Readings
7
7
Non Reproducible Results
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Leak/Splash
1
1
Insufficient Information
1
1
Device Inoperable
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
35
35
No Clinical Signs, Symptoms or Conditions
19
19
Death
1
1
No Code Available
1
1
No Consequences Or Impact To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Accriva Diagnostics, Inc.
II
May-20-2022
2
Accumetrics Inc
II
Mar-11-2014
3
Accumetrics Inc
II
Dec-11-2013
4
Accumetrics Inc
II
Jun-21-2012
5
Aggredyne, Inc.
II
Aug-26-2022
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