INNOVACON SPECTRUM II TEST CARD

Enzyme Immunoassay, Amphetamine

INNOVACON, INC.

The following data is part of a premarket notification filed by Innovacon, Inc. with the FDA for Innovacon Spectrum Ii Test Card.

Pre-market Notification Details

Device IDK061718
510k NumberK061718
Device Name:INNOVACON SPECTRUM II TEST CARD
ClassificationEnzyme Immunoassay, Amphetamine
Applicant INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactEdward Tung
CorrespondentEdward Tung
INNOVACON, INC. 4106 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeDKZ  
Subsequent Product CodeDIO
Subsequent Product CodeDIS
Subsequent Product CodeDJC
Subsequent Product CodeDJG
Subsequent Product CodeDJR
Subsequent Product CodeJXM
Subsequent Product CodeJXN
Subsequent Product CodeLCM
Subsequent Product CodeLDJ
Subsequent Product CodeLFG
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-19
Decision Date2006-11-13
Summary:summary

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