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TPLC
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show TPLC since
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Device
colorimetric method, cpk or isoenzymes
Product Code
JHY
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
MEDICA CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
2
SIEMENS HEALTHCARE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
2
2
2016
4
4
2017
11
11
2018
5
5
2019
2
2
2020
2
2
2022
1
1
2023
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
25
25
Low Test Results
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Incorrect Or Inadequate Test Results
2
2
Non Reproducible Results
1
1
Complete Blockage
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
8
8
No Clinical Signs, Symptoms or Conditions
4
4
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
BioCheck Inc
II
Mar-11-2011
2
Siemens Healthcare Diagnostics, Inc.
II
May-04-2018
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