ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE

Enzyme Immunoassay, Opiates

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Oxy Ii One Step Oxycodone Test Strip; Test Device.

Pre-market Notification Details

Device IDK043507
510k NumberK043507
Device Name:ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE
ClassificationEnzyme Immunoassay, Opiates
Applicant ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactEdward Tung
CorrespondentEdward Tung
ACON LABORATORIES, INC. 4108 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-12-20
Decision Date2005-02-25
Summary:summary

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