BIO-MONITOR AMIKACIN

Amikacin Serum Assay

MONITOR SCIENCE CORP.

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

Pre-market Notification Details

Device IDK780949
510k NumberK780949
Device Name:BIO-MONITOR AMIKACIN
ClassificationAmikacin Serum Assay
Applicant MONITOR SCIENCE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKLP  
CFR Regulation Number862.3035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-06-09
Decision Date1978-08-14

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