The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Inverness Medical Ovulation Predictor Test.
| Device ID | K002867 |
| 510k Number | K002867 |
| Device Name: | INVERNESS MEDICAL OVULATION PREDICTOR TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Contact | Carol A Adiletto |
| Correspondent | Carol A Adiletto SELFCARE, INC. 200 PROSPECT ST. Waltham, MA 02154 -3457 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10492450308633 | K002867 | 000 |
| 00041220524426 | K002867 | 000 |