PRECEPT ERYTHROMYCIN

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 Erythromycin.

Pre-market Notification Details

Device IDK853053
510k NumberK853053
Device Name:PRECEPT ERYTHROMYCIN
ClassificationSusceptibility Test Cards, Antimicrobial
Applicant AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin,  TX  78723
ContactDennis R Schneider
CorrespondentDennis R 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 Received1985-07-19
Decision Date1985-08-29

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