The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Preview(r) Ebv (eia).
| Device ID | K895765 |
| 510k Number | K895765 |
| Device Name: | LEECO PREVIEW(R) EBV (EIA) |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | LEECO DIAGNOSTICS, INC. 24475 WEST TEN MILE RD. Southfield, MI 48034 |
| Contact | Dante J Capaldi,phd |
| Correspondent | Dante J Capaldi,phd LEECO DIAGNOSTICS, INC. 24475 WEST TEN MILE RD. Southfield, MI 48034 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1989-10-31 |