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510(k) K042479

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE by Ortho-Clinical Diagnostics, Inc. — Product Code LCD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2005
Date Received
September 13, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Gentamicin
Device Class
Class II
Regulation Number
862.3450
Review Panel
TX
Submission Type

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  • K210858 — VITROS Chemistry Products PHBR Slides (August 13, 2021)
  • K191316 — VITROS XT Chemistry Products ALB-TP Slides (June 7, 2019)
  • K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides (April 26, 2019)
  • K190520 — VITROS XT Chemistry Products GLU-Ca Slides (April 3, 2019)
  • K190490 — VITROS XT Chemistry Products TRIG-CHOL Slides (March 27, 2019)
  • K190326 — VITROS XT Chemistry Products UREA-CREA Slides (March 14, 2019)
  • K182072 — VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITR (October 30, 2018)

Other clearances for product code LCD

  • K243500 — ARCHITECT iGentamicin (July 9, 2025)
  • K102699 — ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (April 1, 2011)
  • K060709 — MULTIGENT GENTAMICIN (June 15, 2006)
  • K020704 — ROCHE ONLINE GENTAMICIN (July 12, 2002)
  • K012978 — RANDOX GENTAMICIN (September 18, 2001)
  • K012311 — IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) (August 20, 2001)
  • K010984 — EMIT 2000 GENTAMICIN PLUS ASSAY (April 20, 2001)
  • K962819 — GENTAMICIN FLEX REAGENT CARTRIDGE (September 13, 1996)
  • K962519 — EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (September 4, 1996)
  • K953020 — ACS GENTAMICIN (August 2, 1995)