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510(k) K904226

'TDXFLX ANALYZER by Abbott Laboratories — Product Code LCQ

K904226 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "'TDXFLX ANALYZER". The FDA issued a decision of Substantially Equivalent on October 29, 1990. The device falls under product code LCQ (Fluorescent Immunoassay Gentamicin), a Class II device regulated under 21 CFR 862.3450. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1990
Date Received
September 13, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K222850 — HAVAb IgG II (August 10, 2023)
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  • K220282 — i-STAT PTplus Cartridge with the i-STAT 1 System (July 14, 2023)
  • K230937 — Alinity i Total ß-hCG Reagent Kit, GLP systems Track (June 5, 2023)

Other clearances for product code LCQ

  • K972609 — VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM (August 6, 1997)
  • K955569 — INNOFLUOR GENTAMICIN ASSAY SYSTEM (February 9, 1996)
  • K945523 — COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS (March 9, 1995)
  • K943550 — GENTAMICIN FPIA REAGENT SET AND CALIBRATORS (November 17, 1994)
  • K905721 — OPUS GENTAMICIN (February 21, 1991)
  • K894523 — FPR GENTAMICIN KIT (September 28, 1989)
  • K852158 — BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA (June 25, 1985)
  • K852013 — GENTAMICIN KIT(FPIA) (June 10, 1985)
  • K843827 — COBAS REAGENTS FOR GENTAMICIN & CALIBRAT (February 1, 1985)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)

FDA data resources