The following data is part of a premarket notification filed by Alexon Biomedical, Inc. with the FDA for Prospect Entamoeba Histolytica Microplate Assay.
| Device ID | K933997 |
| 510k Number | K933997 |
| Device Name: | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY |
| Classification | Antisera, Latex Agglutination, Cryptococcus Neoformans |
| Applicant | ALEXON BIOMEDICAL, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 -1302 |
| Contact | Susan Turner |
| Correspondent | Susan Turner ALEXON BIOMEDICAL, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 -1302 |
| Product Code | GMD |
| CFR Regulation Number | 866.3165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-17 |
| Decision Date | 1993-11-22 |