The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy Earliest Results Pregnancy Test.
| Device ID | K040341 |
| 510k Number | K040341 |
| Device Name: | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | UNIPATH LTD. PRIORY BUSINESS PARK Bedford, GB Mk44 3up |
| Contact | Louise Roberts |
| Correspondent | Louise Roberts UNIPATH LTD. PRIORY BUSINESS PARK Bedford, GB Mk44 3up |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-12 |
| Decision Date | 2004-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00633472601323 | K040341 | 000 |