Device |
fluorometric method, cpk or isoenzymes |
Regulation Description |
Creatine phosphokinase/creatine kinase or isoenzymes test system. |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | JHX |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1215
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|