XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020

Cryptosporidium Spp.

REMEL INC

The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Cryptosporidium Lateral Flow Assay, Model 2451020.

Pre-market Notification Details

Device IDK031965
510k NumberK031965
Device Name:XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
ClassificationCryptosporidium Spp.
Applicant REMEL INC 1400 UNITY ST. NORTHWEST Ramsey,  MN  55303
ContactRichard Tyson
CorrespondentRichard Tyson
REMEL INC 1400 UNITY ST. NORTHWEST Ramsey,  MN  55303
Product CodeMHJ  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-11-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838026898 K031965 000

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