CEDIA(R) TOBRAMYCIN ASSAY

Fluorescence Polarization Immunoassay, Tobramycin

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia(r) Tobramycin Assay.

Pre-market Notification Details

Device IDK912143
510k NumberK912143
Device Name:CEDIA(R) TOBRAMYCIN ASSAY
ClassificationFluorescence Polarization Immunoassay, Tobramycin
Applicant MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
ContactPatricia M Klimley
CorrespondentPatricia M Klimley
MICROGENICS CORP. 2380A BISSO LN. Concord,  CA  94520
Product CodeLFW  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-15
Decision Date1991-07-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883005631 K912143 000

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