The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Vis-cube Pregnancy Home Test,cat. # Jpl-042.
| Device ID | K863999 |
| 510k Number | K863999 |
| Device Name: | VIS-CUBE PREGNANCY HOME TEST,CAT. # JPL-042 |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-14 |
| Decision Date | 1987-01-09 |