ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE

Enzyme Immunoassay, Amphetamine

ACON LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK011673
510k NumberK011673
Device Name:ACON AMP ONE STEP AMPHETAMINE TEST STRIP, ACON AMP ONE STEP AMPHETAMINE TEST DEVICE
ClassificationEnzyme Immunoassay, Amphetamine
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 CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-05-30
Decision Date2001-07-31
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.