The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Clearblue Easy Early Result Pregnancy Test.
| Device ID | K013372 |
| 510k Number | K013372 |
| Device Name: | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-11 |
| Decision Date | 2001-11-09 |