Definition: A Menopause Test System Is An In Vitro Diagnostic Device Intended To Measure Hormones Or Other Analytes In Human Clinical Specimens As An Aid In The Determination Of Menopausal Status In Women.
| Device Type ID | 683 |
| Device Name | Menopause Test System |
| Physical State | In Vitro Diagnostic Device, Reagent |
| Technical Method | Immunoassay, Other |
| Target Area | Clinical Specimens, E.g. Blood |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1093 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDH |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 683 |
| Device | Menopause Test System |
| Product Code | QDH |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 862.1093 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANSH LABS LLC | ||
GRANTED | 1 | |