The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Early Ovulation Predictor (cassette), One Step Ovulation Predictor (cassette), Ovulation Predictor (cassette).
Device ID | K991466 |
510k Number | K991466 |
Device Name: | EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE) |
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 | 1999-04-27 |
Decision Date | 1999-05-25 |
Summary: | summary |