Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
differential rate kinetic method, cpk or isoenzymes
Product Code
JHS
Regulation Number
862.1215
Device Class
2
Premarket Reviews
Manufacturer
Decision
ROCHE DIAGNOSTICS OPERATIONS (RDO)
SUBSTANTIALLY EQUIVALENT
1
SENTINEL CH. SPA
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
3
3
2015
3
3
2016
1
1
2017
1
1
2018
6
6
2019
6
6
2020
13
13
2021
4
4
2022
3
3
2023
12
12
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
High Test Results
23
23
Low Test Results
21
21
Incorrect, Inadequate or Imprecise Result or Readings
9
9
Non Reproducible Results
4
4
Output Problem
2
2
Incorrect Measurement
2
2
Incorrect Or Inadequate Test Results
2
2
Use of Device Problem
1
1
Material Integrity Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
26
26
No Clinical Signs, Symptoms or Conditions
23
23
No Consequences Or Impact To Patient
5
5
Renal Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ortho Clinical Diagnostics Inc
II
Jan-05-2021
2
Ortho-Clinical Diagnostics
II
May-08-2020
3
Ortho-Clinical Diagnostics
II
Nov-15-2013
4
Siemens Healthcare Diagnostics, Inc
II
Oct-15-2018
-
-