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 |