Device Type ID | 631 |
Device Name | Enzyme Immunoassay, Inhibin-a |
Regulation Description | Estradiol Test System. |
Regulation Medical Specialty | Clinical Chemistry |
Review Panel | Clinical Chemistry |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 862.1260 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NDR |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 631 |
Device | Enzyme Immunoassay, Inhibin-a |
Product Code | NDR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Estradiol Test System. |
CFR Regulation Number | 862.1260 [🔎] |
Device Problems | |
---|---|
High Test Results | 11 |
Total Device Problems | 11 |