MICRODILUTION PANELS

Manual Antimicrobial Susceptibility Test Systems

AMERICAN MICRO SCAN

The following data is part of a premarket notification filed by American Micro Scan with the FDA for Microdilution Panels.

Pre-market Notification Details

Device IDK862140
510k NumberK862140
Device Name:MICRODILUTION PANELS
ClassificationManual Antimicrobial Susceptibility Test Systems
Applicant AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactLorraine Weaver
CorrespondentLorraine Weaver
AMERICAN MICRO SCAN 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeJWY  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-04
Decision Date1986-07-16

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