The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Entamoeba Histolytica-positive Control(rabbit).
| Device ID | K854017 |
| 510k Number | K854017 |
| Device Name: | ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | LMD LABORATORIES 8933 LOMBARD PLACE #215 San Diego, CA 2122 |
| Contact | David Lambillotte |
| Correspondent | David Lambillotte LMD LABORATORIES 8933 LOMBARD PLACE #215 San Diego, CA 2122 |
| Product Code | KHW |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-30 |
| Decision Date | 1985-10-22 |