MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS

Assay, Glycosylated Hemoglobin

SERADYN INC.

The following data is part of a premarket notification filed by Seradyn Inc. with the FDA for Multigent Hemoglobin A1c (reagents), Hb A1c Calibrators And Hb A1c Controls.

Pre-market Notification Details

Device IDK033674
510k NumberK033674
Device Name:MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
ClassificationAssay, Glycosylated Hemoglobin
Applicant SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
ContactLes Padilla
CorrespondentLes Padilla
SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 Indianapolis,  IN  46268 -5260
Product CodeLCP  
Subsequent Product CodeGGM
Subsequent Product CodeKRZ
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-24
Decision Date2004-02-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740003623 K033674 000
00380740003616 K033674 000
00380740003609 K033674 000

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