Seradyn, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
30
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070645SERADYN QMS TOPIRAMATEMay 17, 2007
K062966QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLSJanuary 12, 2007
K062204ARCHITECT CORTISOL ASSAYSeptember 22, 2006
K060998QMS TOBRAMYCINJuly 21, 2006
K060709MULTIGENT GENTAMICINJune 15, 2006
K052826QMS QUINIDINE. QMS QUINIDINE CALIBRATORSDecember 23, 2005
K051211QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLSNovember 18, 2005
K052815QMS AMIKACIN REAGENTSNovember 1, 2005
K050419QMS VANCOMYCINApril 1, 2005
K042307ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH)November 3, 2004
K033674MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLSFebruary 9, 2004
K030405QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075April 28, 2003
K023058QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEMOctober 24, 2002
K981496COLOR-SLIDE RFJune 15, 1998
K952544COLORSLIDER RUBELLAJanuary 17, 1996
K942991QMS THEOPHYLLINE CSSeptember 9, 1994
K940374QMS CARBAMAZEPINE ASSAYJune 2, 1994
K940376QMS GENTAMICIN ASSAYJune 2, 1994
K936208VALPROIC ACIDMarch 11, 1994
K934388QMS PHENOBARBITALFebruary 25, 1994