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510(k) K941614

AXSYM TOBRAMYCIN by Abbott Laboratories — Product Code LFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1994
Date Received
April 4, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescence Polarization Immunoassay, Tobramycin
Device Class
Class II
Regulation Number
862.3900
Review Panel
TX
Submission Type

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Other clearances for product code LFW

  • K964670 — ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN (February 4, 1997)
  • K944371 — TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR (November 10, 1994)
  • K912143 — CEDIA(R) TOBRAMYCIN ASSAY (July 26, 1991)
  • K900707 — MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR (April 20, 1990)
  • K894531 — FPR TOBRAMYCIN KIT (September 1, 1989)
  • K872562 — INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET (August 17, 1987)
  • K854392 — TOBRAMYCIN KIT(FPIA)FLUORESCENCE POLARIZATION IMMU (December 5, 1985)
  • K843828 — COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA (February 1, 1985)
  • K841866 — INNOFLOUR TOBRAMYCIN (May 31, 1984)