Quidel Triage® TOX Drug Screen, 94600

Enzyme Immunoassay, Amphetamine

Quidel Cardiovascular Inc.

The following data is part of a premarket notification filed by Quidel Cardiovascular Inc. with the FDA for Quidel Triage® Tox Drug Screen, 94600.

Pre-market Notification Details

Device IDK200363
510k NumberK200363
Device Name:Quidel Triage® TOX Drug Screen, 94600
ClassificationEnzyme Immunoassay, Amphetamine
Applicant Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego,  CA  92121
ContactRachael S Williamson
CorrespondentRachael S Williamson
Quidel Cardiovascular Inc. 9975 Summers Ridge Road San Diego,  CA  92121
Product CodeDKZ  
Subsequent Product CodeDIS
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeJXM
Subsequent Product CodeJXO
Subsequent Product CodeLAF
Subsequent Product CodeLDJ
Subsequent Product CodeLFG
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyToxicology
510k Review PanelToxicology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2020-03-11

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