The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Giardia/cryptosporidium Lateral Flow Assay.
| Device ID | K031834 |
| 510k Number | K031834 |
| Device Name: | XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY |
| Classification | Giardia Spp. |
| Applicant | REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Earleen C Parks |
| Correspondent | Earleen C Parks REMEL INC 12076 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | MHI |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-13 |
| Decision Date | 2003-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838026881 | K031834 | 000 |
| 00848838026874 | K031834 | 000 |