AUSTIN ENTERIC SYSTEM

Culture Media, Multiple Biochemical Test

AUSTIN BIOLOGICAL LABORATORIES

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

Pre-market Notification Details

Device IDK860194
510k NumberK860194
Device Name:AUSTIN ENTERIC SYSTEM
ClassificationCulture Media, Multiple Biochemical Test
Applicant AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin,  TX  78723
ContactSchneider Phd
CorrespondentSchneider Phd
AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin,  TX  78723
Product CodeJSE  
CFR Regulation Number866.2320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-22
Decision Date1986-02-20

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