TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)

Giardia Spp.

TREND SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Trend Scientific, Inc. with the FDA for Trend Giardia Lamblia Direct Detection System (modified Kit).

Pre-market Notification Details

Device IDK952467
510k NumberK952467
Device Name:TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
ClassificationGiardia Spp.
Applicant TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton,  MN  55112 -0266
ContactMariellyn Truax
CorrespondentMariellyn Truax
TREND SCIENTIFIC, INC. P.O. BOX 12266 New Brighton,  MN  55112 -0266
Product CodeMHI  
CFR Regulation Number866.3220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-26
Decision Date1995-11-20

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