ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE

Gas Chromatography, Methamphetamine

ACON LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK011672
510k NumberK011672
Device Name:ACON MAMP ONE STEP METHAMPHETAMINE TEST STRIP, ACON MAMP ONE STEP METHAMPHETAMINE TEST DEVICE
ClassificationGas Chromatography, Methamphetamine
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 CodeLAF  
CFR Regulation Number862.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-30
Decision Date2001-07-31
Summary:summary

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