The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Concep-7-bhcg (eia) Ii (modified).
| Device ID | K861703 |
| 510k Number | K861703 |
| Device Name: | LEECO CONCEP-7-BHCG (EIA) II (MODIFIED) |
| Classification | Agglutination Method, Human Chorionic Gonadotropin |
| Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Contact | James Lee |
| Correspondent | James Lee LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Product Code | JHJ |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-05 |
| Decision Date | 1986-07-29 |