The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Pregnancy Testing Kit.
| Device ID | K861168 |
| 510k Number | K861168 |
| Device Name: | CLEARBLUE PREGNANCY TESTING KIT |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-28 |
| Decision Date | 1986-04-24 |