ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE

Enzyme Immunoassay, Barbiturate

ACON LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK012824
510k NumberK012824
Device Name:ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
ClassificationEnzyme Immunoassay, Barbiturate
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 CodeDIS  
CFR Regulation Number862.3150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-23
Decision Date2001-11-09
Summary:summary

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