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510(k) K051211

QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS by Seradyn, Inc. — Product Code NWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2005
Date Received
May 11, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay, Anti-Seizure Drug
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

To aid in management of patients treated with anti-seizure drug.

Other clearances by Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)
  • K062966 — QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS (January 12, 2007)
  • K062204 — ARCHITECT CORTISOL ASSAY (September 22, 2006)
  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K052826 — QMS QUINIDINE. QMS QUINIDINE CALIBRATORS (December 23, 2005)
  • K052815 — QMS AMIKACIN REAGENTS (November 1, 2005)
  • K050419 — QMS VANCOMYCIN (April 1, 2005)
  • K042307 — ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (November 3, 2004)
  • K033674 — MULTIGENT HEMOGLOBIN A1C (REAGENTS), HB A1C CALIBRATORS AND HB A1C CONTROLS (February 9, 2004)

Other clearances for product code NWM

  • K201089 — ARK Lacosamide Assay (August 5, 2021)
  • K091884 — ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZONISAMIDE CONTRO, MODE (December 9, 2009)
  • K083799 — TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5 (April 16, 2009)
  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 2007)