The following data is part of a premarket notification filed by Lmd Laboratories with the FDA for Entamoeba Histolytica Hk-9 Antigen (axenic).
| Device ID | K844141 |
| 510k Number | K844141 |
| Device Name: | ENTAMOEBA HISTOLYTICA HK-9 ANTIGEN (AXENIC) |
| Classification | Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Applicant | LMD LABORATORIES 8933 LOMBARD PLACE #215 San Diego, CA 2122 |
| Contact | David N Lambillotte |
| Correspondent | David N 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 | 1984-10-23 |
| Decision Date | 1984-12-06 |