The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Vis-disk Hcg (eia) Jpl-041m.
Device ID | K891096 |
510k Number | K891096 |
Device Name: | VIS-DISK HCG (EIA) JPL-041M |
Classification | System, Test, Human Chorionic Gonadotropin |
Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Contact | Capaldi Phd |
Correspondent | 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 |