ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE

Enzyme Immunoassay, Methadone

ACON LABORATORIES, INC.

The following data is part of a premarket notification filed by Acon Laboratories, Inc. with the FDA for Acon Mtd One Step Methadone Test Strip And Test Device.

Pre-market Notification Details

Device IDK012595
510k NumberK012595
Device Name:ACON MTD ONE STEP METHADONE TEST STRIP AND TEST DEVICE
ClassificationEnzyme Immunoassay, Methadone
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 CodeDJR  
CFR Regulation Number862.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-10
Decision Date2001-10-15
Summary:summary

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