The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Cryptosporidium Lateral Flow Assay, Model 2451020.
| Device ID | K031965 |
| 510k Number | K031965 |
| Device Name: | XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020 |
| Classification | Cryptosporidium 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 | MHJ |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838026898 | K031965 | 000 |