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 |