The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy.
Device ID | K905742 |
510k Number | K905742 |
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 | 1990-12-24 |
Decision Date | 1991-02-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CLEARBLUE EASY 73775070 1615391 Dead/Cancelled |
UNIPATH LIMITED 1989-01-17 |