PRECEPT CEFTRIAXONE

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 Ceftriaxone.

Pre-market Notification Details

Device IDK853273
510k NumberK853273
Device Name:PRECEPT CEFTRIAXONE
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 Received1985-08-05
Decision Date1985-09-16

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