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510(k) K063145

PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS by Thermo Electron OY — Product Code DIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2007
Date Received
October 16, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
Submission Type

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  • K063838 — LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (September 27, 2007)
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  • 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 DIP

  • K080696 — ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1 (September 11, 2008)
  • K030428 — ROCHE ONLINE TDM PHENYTOIN (April 28, 2003)
  • K011393 — RANDOX PHENYTOIN (December 4, 2001)
  • K011347 — EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (May 17, 2001)
  • K000006 — IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2 (February 28, 2000)
  • K993026 — ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (January 27, 2000)
  • K973414 — ACE PHENYTOIN REAGENT, AED CALIBRATORS (November 4, 1997)
  • K963840 — CEDIA PHENYTOIN II ASSAY (November 20, 1996)
  • K943980 — IL TEST PHENYTION CALIBRATORS (May 1, 1995)
  • K945725 — PHENYTION EIA TEST (February 3, 1995)