ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE

Enzyme Immunoassay, Benzodiazepine

ACON LABORATORIES, INC.

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

Pre-market Notification Details

Device IDK012300
510k NumberK012300
Device Name:ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP; ACON BZO ONE STEP BENZODIAZEPINES TEST DEVICE
ClassificationEnzyme Immunoassay, Benzodiazepine
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 CodeJXM  
CFR Regulation Number862.3170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-20
Decision Date2001-09-17
Summary:summary

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