The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Early Ovulation Predictor (stick), One Step Ovulation Predictor (stick), Ovulation Predictor (stick).
| Device ID | K991386 |
| 510k Number | K991386 |
| Device Name: | EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK) |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Carol Adiletto |
| Correspondent | Carol Adiletto SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-21 |
| Decision Date | 1999-05-25 |
| Summary: | summary |