The following data is part of a premarket notification filed by Phamatech with the FDA for Ovustick Lh Ovulation Predictor, Model 9030, Ovucard Lh Ovulation Predictor, Model 9031.
| Device ID | K990249 |
| 510k Number | K990249 |
| Device Name: | OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031 |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Contact | Carl Mongiovi |
| Correspondent | Carl Mongiovi PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego, CA 92126 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-26 |
| Decision Date | 1999-03-22 |