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510(k) K840867

ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN by Intl. Diagnostic Technology — Product Code DEI

K840867 is an FDA 510(k) premarket notification submitted by Intl. Diagnostic Technology for the device "ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN". The FDA issued a decision of Substantially Equivalent on May 11, 1984. The device falls under product code DEI (Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5130. Intl. Diagnostic Technology has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1984
Date Received
February 27, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5130
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)
  • 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)
  • 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 DEI

  • K772250 — ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY (December 22, 1977)

FDA data resources