The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Moments Menopause Check, Model 9113.
| Device ID | K043599 |
| 510k Number | K043599 |
| Device Name: | MOMENTS MENOPAUSE CHECK, MODEL 9113 |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Contact | Carl A Mongiovi |
| Correspondent | Carl A Mongiovi PHAMATECH INC. 10151 BARNES CANYON RD San Diego, CA 92121 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-29 |
| Decision Date | 2005-02-25 |
| Summary: | summary |