The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Vis-disk Strep-a (eia).
| Device ID | K894122 |
| 510k Number | K894122 |
| Device Name: | LEECO VIS-DISK STREP-A (EIA) |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Contact | Dante Capaldi |
| Correspondent | Dante Capaldi LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-12 |
| Decision Date | 1989-08-15 |