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510(k) K033809

DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D by Dade Behring, Inc. — Product Code KLR

K033809 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D". The FDA issued a decision of Substantially Equivalent on February 20, 2004. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2004
Date Received
December 8, 2003
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

Other clearances by Dade Behring, Inc.

  • K093848 — PT-MULTI-CALIBRATOR, MODEL OPAT07 (December 20, 2010)
  • K081161 — DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEI (July 28, 2008)
  • K081249 — DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROT (July 21, 2008)
  • K071603 — DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) (June 25, 2008)
  • K071597 — DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (June 4, 2008)
  • K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CAR (March 13, 2008)
  • K073561 — DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA (February 26, 2008)
  • K073072 — DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B (February 21, 2008)
  • K073055 — DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 (January 3, 2008)
  • K072965 — DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON (December 21, 2007)

Other clearances for product code KLR

  • K090282 — QMS LIDOCAINE (May 29, 2009)
  • 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)
  • K833381 — VALPROIC ACID ANALYTICAL TEST PACK (December 27, 1983)
  • K833379 — LIDOCAINE ANALYTICAL TEST PACK ACA (December 27, 1983)
  • K833623 — MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY (December 8, 1983)
  • K832799 — MODIFICA- OF EMIT CAD LIDOCAINE ASSAY (October 14, 1983)

FDA data resources