The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy.
| Device ID | K911566 |
| 510k Number | K911566 |
| Device Name: | CLEARBLUE EASY |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | Mark Gittins |
| Correspondent | Mark Gittins 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 | 1991-04-09 |
| Decision Date | 1991-05-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CLEARBLUE EASY 73775070 1615391 Dead/Cancelled |
UNIPATH LIMITED 1989-01-17 |