The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Trichinella Serology Microtiter Elisa.
| Device ID | K904613 |
| 510k Number | K904613 |
| Device Name: | TRICHINELLA SEROLOGY MICROTITER ELISA |
| Classification | Antigen, Latex Agglutination, Trichinella Spiralis |
| Applicant | LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
| Contact | Dave Lambillotte |
| Correspondent | Dave Lambillotte LMD LABORATORIES 4626 SANTA FE ST. San Diego, CA 92109 |
| Product Code | GPG |
| CFR Regulation Number | 866.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-11 |
| Decision Date | 1991-03-21 |