BIO-MONITOR TOBRAMYCIN

Bacillus Subtilis Microbiology Assay, Tobramycin

MONITOR SCIENCE CORP.

The following data is part of a premarket notification filed by Monitor Science Corp. with the FDA for Bio-monitor Tobramycin.

Pre-market Notification Details

Device IDK780950
510k NumberK780950
Device Name:BIO-MONITOR TOBRAMYCIN
ClassificationBacillus Subtilis Microbiology Assay, Tobramycin
Applicant MONITOR SCIENCE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDID  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-09
Decision Date1978-08-14

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