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 |