The following data is part of a premarket notification filed by Phamatech Inc. with the FDA for Pharmatech Menopause Check, Models 9111 And 9112.
| Device ID | K040575 |
| 510k Number | K040575 |
| Device Name: | PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112 |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | PHAMATECH INC. 10151 BARNES CANYON ROAD San Diego, CA 92121 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH INC. 10151 BARNES CANYON ROAD San Diego, CA 92121 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-04 |
| Decision Date | 2004-05-20 |
| Summary: | summary |