The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for E.p.t. Certainty 1-step Pregnancy Test.
| Device ID | K061769 |
| 510k Number | K061769 |
| Device Name: | E.P.T. CERTAINTY 1-STEP 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 | 2006-06-23 |
| Decision Date | 2006-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10363736993037 | K061769 | 000 |
| 10363736992023 | K061769 | 000 |