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510(k) K801308

FIAX TEST KIT FOR TOBRAMYCIN QUANTITA by Intl. Diagnostic Technology — Product Code LCR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1980
Date Received
June 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Intl. Diagnostic Technology

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  • K843621 — FIAX 420 DILUTOR (September 28, 1984)
  • K843356 — FIAX 100 FLUOROMETER (September 17, 1984)
  • K842749 — FIAX TOTAL IGE TEST KIT (August 28, 1984)
  • K842071 — FIAX TRANSFERRIN TEST KIT (July 11, 1984)
  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K840867 — ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (May 11, 1984)
  • K834140 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS (January 20, 1984)
  • K833984 — ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (January 4, 1984)

Other clearances for product code LCR

  • K060998 — QMS TOBRAMYCIN (July 21, 2006)
  • K974029 — ACS TOBRAMYCIN (February 12, 1998)
  • K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE (September 13, 1996)
  • K952568 — BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (August 8, 1995)
  • K911940 — OPUS(R) TOBRAMYCIN (July 1, 1991)
  • K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 (June 28, 1991)
  • K854873 — INTRAOCULAR PRESSURE REDUCER (February 4, 1986)
  • K850058 — DU PONT TOBRAMYCIN ASSAY REAGENTS (January 18, 1985)
  • K840847 — IMMPULSE TOBRAMYCIN ASSAY REAGENTS (April 4, 1984)
  • K832408 — STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM (August 26, 1983)