QDH — Menopause Test System Class II
FDA product code QDH covers "Menopause Test System", a Class II medical device regulated under 21 CFR 862.1093. Submissions are reviewed by the Clinical Chemistry panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QDH
- Device Class
- Class II
- Regulation Number
- 862.1093
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN180004 | ansh labs | picoAMH ELISA | October 24, 2018 |