Menopause Test System
The 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. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is QDH under regulation 862.1093 in the Clinical Chemistry specialty. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QDH
- Device Class
- FDA class 2
- Regulation Number
- 862.1093
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN180004 | picoAMH ELISA | Oct 24, 2018 | Unknown | Ansh Labs, LLC |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.