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510(k) K791948

FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS by Intl. Diagnostic Technology — Product Code GQH

K791948 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS". The FDA issued a decision of Substantially Equivalent on November 16, 1979. The device falls under product code GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1979
Date Received
October 1, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
Review Panel
MI
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)
  • 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 GQH

  • K982311 — BARTELS CINAKIT CMV ANTIGENEMIA (December 14, 1998)
  • K964875 — CMV ANTIGEN CONTROL SLIDES (March 18, 1997)
  • K935809 — CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY (May 5, 1994)
  • K882835 — INDIRECT FLUORESCENT ASSAY FOR (HCMV) (December 5, 1988)
  • K882024 — FITC MURINE MONOCLONAL ANTI-CMV IGG (August 3, 1988)
  • K881932 — ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT (August 1, 1988)
  • K880679 — BION CMV-G TEST SYSTEM (June 3, 1988)
  • K880290 — MICROTRAK CMV CULTURE CONFIRMATION TEST (April 19, 1988)
  • K872576 — COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION (December 4, 1987)
  • K873114 — CYTOMEGALOVIRUS CONTROL SLIDES (September 25, 1987)

FDA data resources