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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