The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearplan Easy.
| Device ID | K894579 |
| 510k Number | K894579 |
| Device Name: | CLEARPLAN EASY |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Contact | George Zajicek |
| Correspondent | George Zajicek UNIPATH LTD. NORSE ROAD Bedford Mk41 Oqg, GB |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CLEARPLAN EASY 74227736 1858107 Dead/Cancelled |
UNILEVER N. V. 1991-12-06 |