The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearplan Easy Ovulation Test.
| Device ID | K981271 |
| 510k Number | K981271 |
| Device Name: | CLEARPLAN EASY OVULATION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| 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 | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-06-25 |