QMS TOBRAMYCIN

Fluorescent Immunoassay, Tobramycin

SERADYN, INC.

The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Qms Tobramycin.

Pre-market Notification Details

Device IDK060998
510k NumberK060998
Device Name:QMS TOBRAMYCIN
ClassificationFluorescent Immunoassay, Tobramycin
Applicant SERADYN, INC. 7998 GEORGETOWN RD., STE. 1000 Indianapolis,  IN  46268 -5260
ContactEarl E Knight Iii
CorrespondentEarl E Knight Iii
SERADYN, INC. 7998 GEORGETOWN RD., STE. 1000 Indianapolis,  IN  46268 -5260
Product CodeLCR  
CFR Regulation Number862.3900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-11
Decision Date2006-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740154141 K060998 000
00380740013127 K060998 000
00884883012691 K060998 000

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