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510(k) Data Aggregation
K Number
K972156Device Name
QUIX RAPID E. COLI O157 STRIP TEST
Manufacturer
GUARDIAN SCIENTIFIC, CORP.
Date Cleared
1997-10-16
(129 days)
Product Code
GMZ
Regulation Number
866.3255Why did this record match?
Applicant Name (Manufacturer) :
GUARDIAN SCIENTIFIC, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.
Device Description
The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay.
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K Number
K954994Device Name
TRUST
Manufacturer
GUARDIAN SCIENTIFIC, CORP.
Date Cleared
1996-10-18
(353 days)
Product Code
GMQ
Regulation Number
866.3820Why did this record match?
Applicant Name (Manufacturer) :
GUARDIAN SCIENTIFIC, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954995Device Name
QUIX RAPID CHOLERA STRIP TEST
Manufacturer
GUARDIAN SCIENTIFIC, CORP.
Date Cleared
1996-08-15
(289 days)
Product Code
GSQ
Regulation Number
866.3930Why did this record match?
Applicant Name (Manufacturer) :
GUARDIAN SCIENTIFIC, CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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