The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Amebiasis Elisa Test Kit.
| Device ID | K870318 |
| 510k Number | K870318 |
| Device Name: | AMEBIASIS ELISA TEST KIT |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| 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 | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-28 |
| Decision Date | 1987-08-11 |