Device |
ige, fitc, antigen, antiserum, control |
Regulation Description |
Immunoglobulins A, G, M, D, and E immunological test system. |
Regulation Medical Specialty |
Immunology |
Review Panel |
Immunology |
Product Code | DGP |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Immunology and Hematology Devices
(DIHD)
|
Submission Type |
510(k)
|
Regulation Number |
866.5510
|
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
|
|
|