The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Giardia Lateral Flow Assay, Model 2450020.
| Device ID | K031942 |
| 510k Number | K031942 |
| Device Name: | XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020 |
| Classification | Giardia Spp. |
| Applicant | REMEL INC 1400 UNITY ST. NORTHWEST Ramsey, MN 55303 |
| Contact | Richard Tyson |
| Correspondent | Richard Tyson REMEL INC 1400 UNITY ST. NORTHWEST Ramsey, MN 55303 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-24 |
| Decision Date | 2003-11-18 |
| Summary: | summary |