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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
densitometer/scanner (integrating, reflectance, tlc, radiochromat.) clinica
Product Code
JQT
Regulation Number
862.2400
Device Class
1
Premarket Reviews
Manufacturer
Decision
ARLINGTON SCIENTIFIC, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2018
3
3
2019
5
5
2020
11
11
2021
5
5
2022
5
5
2023
6
6
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Electrical /Electronic Property Problem
15
15
Sparking
14
14
Electro-Static Discharge
4
4
Noise, Audible
4
4
Unintended Electrical Shock
4
4
Smoking
3
3
Fail-Safe Problem
3
3
Failure to Power Up
3
3
Physical Resistance/Sticking
2
2
Electrical Overstress
1
1
Incorrect Or Inadequate Test Results
1
1
Temperature Problem
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Overheating of Device
1
1
Failure to Eject
1
1
Fire
1
1
Device Markings/Labelling Problem
1
1
Power Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
22
22
No Known Impact Or Consequence To Patient
7
7
Electric Shock
6
6
No Consequences Or Impact To Patient
2
2
No Code Available
1
1
Numbness
1
1
Insufficient Information
1
1
Pain
1
1
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