The following data is part of a premarket notification filed by Alexon, Inc. with the FDA for Prospec T/giardia Rapid Assay.
| Device ID | K911337 |
| 510k Number | K911337 |
| Device Name: | PROSPEC T/GIARDIA RAPID ASSAY |
| Classification | Giardia Spp. |
| Applicant | ALEXON, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Terri A Marello |
| Correspondent | Terri A Marello ALEXON, INC. 2319 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-26 |
| Decision Date | 1991-09-27 |