# K040575: Pharmatech Menopause Check, Models 9111 and 9112

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech, Inc.
- Decided: May 20, 2004 after 77 days
- Product code: CGJ (Radioimmunoassay, Follicle-Stimulating Hormone)
- Device class: 1
- Regulation: 21 CFR 862.1300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synova Menocheck: named in the summary without a submission number
- (no number) Applied Biotech SureStep FSH: named in the summary without a submission number

## Indications for use
The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.

Source page: https://510kreport.com/device/K040575
Methodology: https://510kreport.com/methodology