The following data is part of a premarket notification filed by Alexon Biomedical, Inc. with the FDA for Prospect Ii Clostridium Diffillie Toxin A Microplate Assay.
| Device ID | K964864 |
| 510k Number | K964864 |
| Device Name: | PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| 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 | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-04 |
| Decision Date | 1997-02-04 |