The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Right-day Ovulation Home Test.
Device ID | K861354 |
510k Number | K861354 |
Device Name: | RIGHT-DAY OVULATION HOME TEST |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Contact | Lee, Ph.d. |
Correspondent | Lee, Ph.d. LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-10 |
Decision Date | 1986-09-16 |