Fiax Total Ige Test Kit

FDA 510(k) K842749 · Intl. Diagnostic Technology

Substantially Equivalent

510(k) numberK842749

Submission

Device name
Fiax Total Ige Test Kit
Applicant
Intl. Diagnostic Technology
Mchenry, IL, US
Received
July 13, 1984
Decision date
August 28, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DGP – Ige, Fitc, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Specialty
Immunology

Other 510(k)s with product code DGP

510(k)DeviceApplicantDecision
K931224Vidas Total Ige (Ige) AssayDGP · Traditional Biomerieux Vitek, Inc.05/20/1993SE
K863327Immpulse Ige Assay ReagentsDGP · Traditional Sclavo, Inc.12/03/1986SE
K842969Allergenetics Aller-Specific Ige SerumDGP · Traditional Allergenetics08/28/1984SE

More from Allergenetics

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
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
K832821Fiax Igg TestDFI · Traditional 10/14/1983SE

Questions and answers

When was Fiax Total Ige Test Kit cleared by the FDA?

Fiax Total Ige Test Kit (K842749) received a 510(k) decision of Substantially Equivalent on August 28, 1984, 46 days after the submission was received.

What is the product code of K842749?

The FDA product code is DGP – Ige, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.