The following data is part of a premarket notification filed by Genua 1944, Inc. with the FDA for Genua Menopause Monitor Test Kit.
| Device ID | K002450 |
| 510k Number | K002450 |
| Device Name: | GENUA MENOPAUSE MONITOR TEST KIT |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | GENUA 1944, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus GENUA 1944, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2001-01-12 |