Fiax Haptoglobin Test Kit

FDA 510(k) K843570 · Intl. Diagnostic Technology

Substantially Equivalent

510(k) numberK843570

Submission

Device name
Fiax Haptoglobin Test Kit
Applicant
Intl. Diagnostic Technology
Mchenry, IL, US
Received
September 11, 1984
Decision date
October 5, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DAB – Haptoglobin, Fitc, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5460
Specialty
Immunology

Other 510(k)s with product code DAB

510(k)DeviceApplicantDecision
K913670Haptoglobin Immunological Test KitDAB · Traditional The Binding Site, Ltd.12/09/1991SE
K772078Radial Immunodiffusion Kit-HaptoglobinDAB · Traditional Gelman Instrument Co.02/03/1978SE

More from Gelman Instrument Co.

510(k)DeviceDecision
K850591Fiax Toxo-M Antibodies Test KitGLZ · Traditional 04/30/1985SE
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
K832821Fiax Igg TestDFI · Traditional 10/14/1983SE

Questions and answers

When was Fiax Haptoglobin Test Kit cleared by the FDA?

Fiax Haptoglobin Test Kit (K843570) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 24 days after the submission was received.

What is the product code of K843570?

The FDA product code is DAB – Haptoglobin, Fitc, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5460.