The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Vis-disk Hcg (eia) Lyophilized Jpl-044m.
| Device ID | K891095 |
| 510k Number | K891095 |
| Device Name: | VIS-DISK HCG (EIA) LYOPHILIZED JPL-044M |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Contact | Dante J Capaldi,phd |
| Correspondent | Dante J Capaldi,phd LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-02 |
| Decision Date | 1989-06-16 |