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510(k) K090282

QMS LIDOCAINE by Thermo Fisher Scientific, Inc. — Product Code KLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2009
Date Received
February 5, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Lidocaine
Device Class
Class II
Regulation Number
862.3555
Review Panel
TX
Submission Type

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Other clearances for product code KLR

  • K033809 — DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRA (February 20, 2004)
  • K032334 — ROCHE ONLINE TDM LIDOCAINE (January 12, 2004)
  • K973102 — LIDOCAINE EIA ASSAY (September 12, 1997)
  • K881116 — EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (June 20, 1988)
  • K853010 — COBAS REAGENT FOR LIDOCAINE & CALIBRATORS (August 7, 1985)
  • K843184 — STRATUS LIDOCAINE FLUOROMETRIC ENZYME (September 26, 1984)
  • K833379 — LIDOCAINE ANALYTICAL TEST PACK ACA (December 27, 1983)
  • K833381 — VALPROIC ACID ANALYTICAL TEST PACK (December 27, 1983)
  • K833623 — MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (December 8, 1983)
  • K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (October 14, 1983)