PRECEPT KANAMYCIN

Susceptibility Test Cards, Antimicrobial

AUSTIN BIOLOGICAL LABORATORIES

The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept Kanamycin.

Pre-market Notification Details

Device IDK853684
510k NumberK853684
Device Name:PRECEPT KANAMYCIN
ClassificationSusceptibility Test Cards, Antimicrobial
Applicant AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin,  TX  78723
ContactRay Schneider
CorrespondentRay Schneider
AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin,  TX  78723
Product CodeLTW  
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-22
Decision Date1985-09-13

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