The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Inverness Medical Early Pregnancy Test.
| Device ID | K002049 |
| 510k Number | K002049 |
| Device Name: | INVERNESS MEDICAL EARLY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-07-27 |