The following data is part of a premarket notification filed by Alexon, Inc. with the FDA for Prospect Microplate Assay.
| Device ID | K934493 |
| 510k Number | K934493 |
| Device Name: | PROSPECT MICROPLATE ASSAY |
| Classification | Reagents, Clostridium Difficile Toxin |
| Applicant | ALEXON, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 |
| Contact | Susan Turner, Phd |
| Correspondent | Susan Turner, Phd ALEXON, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 |
| Product Code | LLH |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-15 |
| Decision Date | 1994-09-20 |