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510(k) K042808

ADVIA IMS CARBAMAZEPINE METHOD by Bayer Healthcare, LLC — Product Code KLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2005
Date Received
October 12, 2004
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

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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)
  • 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)
  • K993987 — SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL (January 27, 2000)