Fiax Igg Test

FDA 510(k) K832821 · Intl. Diagnostic Technology

Substantially Equivalent

510(k) numberK832821

Submission

Device name
Fiax Igg Test
Applicant
Intl. Diagnostic Technology
Mchenry, IL, US
Received
August 19, 1983
Decision date
October 14, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DFI – Total Spinal-Fluid, Antigen, Antiserum, Control
Device class
Class I (low risk)
Regulation
21 CFR 866.5860
Specialty
Immunology

Other 510(k)s with product code DFI

510(k)DeviceApplicantDecision
K854190Cantrol Spinal Fluid ControlDFI · Traditional Canyon Diagnostics, Inc.11/25/1985SE
K843122Resolve-CsfDFI · Traditional Isolab, Inc.11/30/1984SE
K840974Somas Human Spinal Fluid ControlDFI · Traditional Somas Medical Industries, Inc.04/05/1984SE

More from Somas Medical Industries, Inc.

510(k)DeviceDecision
K850591Fiax Toxo-M Antibodies Test KitGLZ · Traditional 04/30/1985SE
K843570Fiax Haptoglobin Test KitDAB · Traditional 10/05/1984SE
K843621Fiax 420 DilutorJQW · Traditional 09/28/1984SE
K843356Fiax 100 FluorometerJZT · Traditional 09/17/1984SE
K842749Fiax Total Ige Test KitDGP · Traditional 08/28/1984SE
K842071Fiax Transferrin Test KitDDI · Traditional 07/11/1984SE
K841174Rubella Antibody FluoroimmunoassayGOL · Traditional 06/07/1984SE
K840867ALPHA-1-ANTITRYPSIN, Fitc, AntigenDEI · Traditional 05/11/1984SE
K834140Antinuclear Antibody Immunological SysKTL · Traditional 01/20/1984SE
K833984Antinuclear Antibody ImmunologicalKTL · Traditional 01/04/1984SE

Questions and answers

When was Fiax Igg Test cleared by the FDA?

Fiax Igg Test (K832821) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 56 days after the submission was received.

What is the product code of K832821?

The FDA product code is DFI – Total Spinal-Fluid, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5860.