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 |