XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY

Giardia Spp.

REMEL INC

The following data is part of a premarket notification filed by Remel Inc with the FDA for Xpect Giardia/cryptosporidium Lateral Flow Assay.

Pre-market Notification Details

Device IDK031834
510k NumberK031834
Device Name:XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
ClassificationGiardia Spp.
Applicant REMEL INC 12076 SANTA FE DRIVE Lenexa,  KS  66215
ContactEarleen C Parks
CorrespondentEarleen C Parks
REMEL INC 12076 SANTA FE DRIVE Lenexa,  KS  66215
Product CodeMHI  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-13
Decision Date2003-11-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00848838026881 K031834 000
00848838026874 K031834 000

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