QUIX RAPID E. COLI O157 STRIP TEST

Antigens, All Types, Escherichia Coli

GUARDIAN SCIENTIFIC, CORP.

The following data is part of a premarket notification filed by Guardian Scientific, Corp. with the FDA for Quix Rapid E. Coli O157 Strip Test.

Pre-market Notification Details

Device IDK972156
510k NumberK972156
Device Name:QUIX RAPID E. COLI O157 STRIP TEST
ClassificationAntigens, All Types, Escherichia Coli
Applicant GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia,  MD  21045
ContactKathryn B Powers
CorrespondentKathryn B Powers
GUARDIAN SCIENTIFIC, CORP. 8990-E ROUTE 108 Columbia,  MD  21045
Product CodeGMZ  
CFR Regulation Number866.3255 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-09
Decision Date1997-10-16

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