Device |
strip, test isoniazid |
Review Panel |
Toxicology |
Product Code | MIG |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Unclassified Reason
|
Pre-Amendment
|
Submission Type |
510(k)
|
Device Class |
Unclassified
|
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 |
Not Third Party Eligible |
|
|