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510(k) K062966

QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS by Seradyn, Inc. — Product Code ORH

K062966 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "QMS LAMOTRIGINE ASSAY (REAGENTS), CALIBRATORS & CONTROLS". The FDA issued a decision of Substantially Equivalent on January 12, 2007. The device falls under product code ORH (Lamotrigine Assay), a Class II device regulated under 21 CFR 862.3350. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2007
Date Received
September 29, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamotrigine Assay
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

for the quantitative determination of lamotrigine in human serum or plasma on automated clinical chemistry analyzers.

Other clearances by Seradyn, Inc.

  • K070645 — SERADYN QMS TOPIRAMATE (May 17, 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 ORH

  • K101305 — ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL (October 29, 2010)

FDA data resources