The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy Digital Pregnancy Test.
| Device ID | K060128 |
| 510k Number | K060128 |
| Device Name: | CLEARBLUE EASY DIGITAL 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00492450303419 | K060128 | 000 |
| 10011822515266 | K060128 | 000 |
| 10021130163837 | K060128 | 000 |
| 10041163502984 | K060128 | 000 |
| 00633472000041 | K060128 | 000 |
| 10633472602051 | K060128 | 000 |
| 10041220524560 | K060128 | 000 |
| 00041163458291 | K060128 | 000 |
| 10021130790057 | K060128 | 000 |
| 10050428343958 | K060128 | 000 |
| 10041260386296 | K060128 | 000 |
| 10041220524447 | K060128 | 000 |
| 00036800163218 | K060128 | 000 |
| 10050428362270 | K060128 | 000 |
| 10050428316365 | K060128 | 000 |
| 10050428083359 | K060128 | 000 |
| 10050428079239 | K060128 | 000 |
| 10713733805800 | K060128 | 000 |
| 00041220961689 | K060128 | 000 |
| 00311917199368 | K060128 | 000 |
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| 10311917149216 | K060128 | 000 |
| 00633472808760 | K060128 | 000 |
| 10633472601542 | K060128 | 000 |
| 10633472601153 | K060128 | 000 |
| 10633472601146 | K060128 | 000 |
| 00633472155642 | K060128 | 000 |
| 00633472002953 | K060128 | 000 |
| 00633472002908 | K060128 | 000 |
| 00681131157940 | K060128 | 000 |
| 00050428436288 | K060128 | 000 |
| 00050428255445 | K060128 | 000 |
| 00050428253953 | K060128 | 000 |
| 10050428284169 | K060128 | 000 |
| 00036800458475 | K060128 | 000 |
| 10311917055579 | K060128 | 000 |