QMS VANCOMYCIN

Radioimmunoassay, Vancomycin

SERADYN INC.

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

Pre-market Notification Details

Device IDK050419
510k NumberK050419
Device Name:QMS VANCOMYCIN
ClassificationRadioimmunoassay, Vancomycin
Applicant SERADYN INC. 7998 GEORGETOWN RD. Indianapolis,  IN  46268
ContactJack Rogers
CorrespondentJack Rogers
SERADYN INC. 7998 GEORGETOWN RD. Indianapolis,  IN  46268
Product CodeLEH  
CFR Regulation Number862.3950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-18
Decision Date2005-04-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740135348 K050419 000
00380740009847 K050419 000
00884883012837 K050419 000
00884883011182 K050419 000

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