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510(k) K841866

INNOFLOUR TOBRAMYCIN by Innotron Diagnostics — Product Code LFW

K841866 is an FDA 510(k) premarket notification submitted by Innotron Diagnostics for the device "INNOFLOUR TOBRAMYCIN". The FDA issued a decision of Substantially Equivalent on May 31, 1984. The device falls under product code LFW (Fluorescence Polarization Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Innotron Diagnostics has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1984
Date Received
May 4, 1984
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

Other clearances by Innotron Diagnostics

  • K850629 — INNOFLUOR THEOPHYLLINE (March 12, 1985)
  • K844721 — INNOFLUOR PRIMIDONE (January 8, 1985)
  • K841865 — INNOFLOUR GENTAMICIN (May 31, 1984)
  • K841707 — INNOFLUOR PHENOBARBITAL (May 23, 1984)
  • K841706 — INNOFLUOR PHENYTOIN (May 22, 1984)

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)
  • K941614 — AXSYM TOBRAMYCIN (August 18, 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)

FDA data resources