The following data is part of a premarket notification filed by Alexon, Inc. with the FDA for Prospect(tm) Giardia Rapid Assay, Modification.
| Device ID | K931147 |
| 510k Number | K931147 |
| Device Name: | PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION |
| Classification | Giardia Spp. |
| Applicant | ALEXON, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 |
| Contact | Susan Turner |
| Correspondent | Susan Turner ALEXON, INC. 1190 BORREGAS AVE. Sunnyvale, CA 94089 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-05 |
| Decision Date | 1993-05-13 |