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510(k) K063131

CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS by Thermo Electron OY — Product Code KLT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2007
Date Received
October 13, 2006
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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  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
  • K063086 — TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS (August 8, 2007)
  • K061412 — THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 (March 23, 2007)
  • K063209 — HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL (March 21, 2007)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K063647 — CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH (March 12, 2007)
  • K061107 — DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 (August 8, 2006)

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