QMS QUINIDINE. QMS QUINIDINE CALIBRATORS

Enzyme Immunoassay, Quinidine

SERADYN INC.

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

Pre-market Notification Details

Device IDK052826
510k NumberK052826
Device Name:QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
ClassificationEnzyme Immunoassay, Quinidine
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
ContactJack Rogers
CorrespondentJack Rogers
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
Product CodeLBZ  
CFR Regulation Number862.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-05
Decision Date2005-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740011222 K052826 000
00884883006003 K052826 000
00884883005990 K052826 000
00380740011215 K052826 000

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