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FDA 510(k) Applications Submitted by SERADYN INC.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K060709
03/16/2006
MULTIGENT GENTAMICIN
SERADYN INC.
K062204
08/01/2006
ARCHITECT CORTISOL ASSAY
SERADYN INC.
K050419
02/18/2005
QMS VANCOMYCIN
SERADYN INC.
K070645
03/08/2007
SERADYN QMS TOPIRAMATE
SERADYN INC.
K051211
05/11/2005
QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS
SERADYN INC.
K042307
08/25/2004
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)
SERADYN INC.
K062966
09/29/2006
QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS
SERADYN INC.
K052815
10/04/2005
QMS AMIKACIN REAGENTS
SERADYN INC.
K052826
10/05/2005
QMS QUINIDINE. QMS QUINIDINE CALIBRATORS
SERADYN INC.
K033674
11/24/2003
MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS
SERADYN INC.
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