Device |
hemoglobin a1c test system |
Regulation Description |
Hemoglobin A1c test system. |
Definition |
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes. |
Physical State |
In-Vitro Diagnostic Reagent Kit |
Technical Method |
Assay detecting glycated hemoglobin |
Target Area |
Whole blood |
Regulation Medical Specialty |
Clinical Chemistry |
Review Panel |
Clinical Chemistry |
Product Code | PDJ |
Premarket Review |
Division of Chemistry and Toxicology Devices
(DCTD)
Division of Chemistry and Toxicology Devices
(DCTD)
|
Submission Type |
510(k)
|
Regulation Number |
862.1373
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |