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510(k) K070645

SERADYN QMS TOPIRAMATE by Seradyn, Inc. — Product Code NWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2007
Date Received
March 8, 2007
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.

  • 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)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 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)
  • K051211 — QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS (November 18, 2005)