The following data is part of a premarket notification filed by Alexon Biomedical, Inc. with the FDA for Prospect Cryptosporidium Rapid Assay.
| Device ID | K936191 |
| 510k Number | K936191 |
| Device Name: | PROSPECT CRYPTOSPORIDIUM RAPID ASSAY |
| Classification | Cryptosporidium Spp. |
| Applicant | ALEXON BIOMEDICAL, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 -1302 |
| Contact | Susan Turner, Ph.d |
| Correspondent | Susan Turner, Ph.d ALEXON BIOMEDICAL, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 -1302 |
| Product Code | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-11-17 |