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 |