The following data is part of a premarket notification filed by Spd Development Company Limited with the FDA for Clearblue Easy Pregnancy Test.
| Device ID | K110433 |
| 510k Number | K110433 |
| Device Name: | CLEARBLUE EASY PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | SPD DEVELOPMENT COMPANY LIMITED STANNARD WAY PRIORY BUSINESS PARK Bedford, Bedfordshire, GB Mk44 3up |
| Contact | Tanya Fair |
| Correspondent | Tanya Fair SPD DEVELOPMENT COMPANY LIMITED STANNARD WAY PRIORY BUSINESS PARK Bedford, Bedfordshire, 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 | 2011-02-15 |
| Decision Date | 2011-05-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10633472601023 | K110433 | 000 |
| 00633472322587 | K110433 | 000 |
| 00633472249631 | K110433 | 000 |
| 00633472222788 | K110433 | 000 |
| 10633472601849 | K110433 | 000 |
| 10633472601719 | K110433 | 000 |
| 10633472602235 | K110433 | 000 |