The following data is part of a premarket notification filed by Cambridge Diagnostics Ireland, Ltd. with the FDA for Selfcare Early Pregnancy Test.
| Device ID | K955903 |
| 510k Number | K955903 |
| Device Name: | SELFCARE EARLY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK Galway, IE |
| Contact | Kathleen M ,clough |
| Correspondent | Kathleen M ,clough CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK 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 | 1995-12-29 |
| Decision Date | 1996-03-06 |