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510(k) K843356

FIAX 100 FLUOROMETER by Intl. Diagnostic Technology — Product Code JZT

K843356 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX 100 FLUOROMETER". The FDA issued a decision of Substantially Equivalent on September 17, 1984. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1984
Date Received
August 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer
Device Class
Class I
Regulation Number
866.4520
Review Panel
IM
Submission Type

Other clearances by Intl. Diagnostic Technology

  • K850591 — FIAX TOXO-M ANTIBODIES TEST KIT (April 30, 1985)
  • K843570 — FIAX HAPTOGLOBIN TEST KIT (October 5, 1984)
  • K843621 — FIAX 420 DILUTOR (September 28, 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)
  • K832821 — FIAX IGG TEST (October 14, 1983)

Other clearances for product code JZT

  • K962499 — ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (September 5, 1996)
  • K883349 — QLIA IMMUNOCHEMISTRY SYSTEM (September 7, 1988)
  • K882677 — STAT-20 FLUOROMETER (July 12, 1988)
  • K864699 — FLUORESCENCE CONCENTRATION ANALYZER (FCA) (December 22, 1986)
  • K863434 — THE FIAX 5000 FLUOROMETER (October 29, 1986)
  • K862674 — PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM (August 15, 1986)
  • K852240 — SMS, SCREEN MACHINE SYSTEM (June 11, 1985)
  • K842049 — FLUOROSKAN (December 3, 1984)
  • K834070 — IMMPULSE SYSTEM (March 23, 1984)
  • K831870 — ALLERGENETICS FLUORO-FAST READER (August 12, 1983)

FDA data resources