The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearplane Easy Ovulation Test.
| Device ID | K013874 |
| 510k Number | K013874 |
| Device Name: | CLEARPLANE EASY OVULATION TEST |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | UNIPATH LTD. 390 PARK AVE. New York, NY 10022 -4698 |
| Contact | Steven H Armstrong |
| Correspondent | Steven H Armstrong UNIPATH LTD. 390 PARK AVE. New York, NY 10022 -4698 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-21 |
| Decision Date | 2002-02-19 |