The following data is part of a premarket notification filed by Selfcare, Inc. with the FDA for Selfcare Early Pregnancy Test.
| Device ID | K960436 |
| 510k Number | K960436 |
| Device Name: | SELFCARE EARLY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SELFCARE, INC. MERVUE INDUSTRIAL ESTATE Galway, IE |
| Contact | Kathleen M Clough |
| Correspondent | Kathleen M Clough SELFCARE, INC. MERVUE INDUSTRIAL ESTATE Galway, IE |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-31 |
| Decision Date | 1996-03-19 |