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510(k) K940374

QMS CARBAMAZEPINE ASSAY by Seradyn, Inc. — Product Code KLT

K940374 is an FDA 510(k) premarket notification submitted by Seradyn, Inc. for the device "QMS CARBAMAZEPINE ASSAY". The FDA issued a decision of Substantially Equivalent on June 2, 1994. The device falls under product code KLT (Enzyme Immunoassay, Carbamazepine), a Class II device regulated under 21 CFR 862.3645. Seradyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1994
Date Received
January 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Carbamazepine
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

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)
  • 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)

Other clearances for product code KLT

  • K151578 — Carbamazepine Gen 4 (October 22, 2015)
  • K123518 — ABBOTT CARBAMAZEPINE ASSAY (June 5, 2013)
  • K103627 — ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIB (October 14, 2011)
  • K063131 — CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS (October 5, 2007)
  • K042808 — ADVIA IMS CARBAMAZEPINE METHOD (February 8, 2005)
  • K031902 — ONLINE TDM CARBAMAZEPINE (September 17, 2003)
  • K011648 — RANDOX CARBAMAZEPINE (January 15, 2002)
  • K010814 — EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229 (April 13, 2001)
  • K000903 — ADDITIONAL ASSAYS FOR BAYER ADVIA IMS SYSTEM (May 18, 2000)
  • K000007 — IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2 (February 28, 2000)

FDA data resources