Fiax Test for Anti-Rubella Antibody

Q: What is the product code of K772219?

The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.

FDA 510(k) K772219 · Idt, A Division of Whittaker M.A. Bioproducts

Substantially Equivalent

510(k) numberK772219

Submission

Device name: Fiax Test for Anti-Rubella Antibody
Applicant: Idt, A Division of Whittaker M.A. Bioproducts
Mchenry, IL, US
Received: December 5, 1977
Decision date: January 20, 1978
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5100
Specialty: Immunology

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More from Corgenix, Inc.

510(k)	Device	Decision
K853540	Fiax Test Kit for Varicella Antibody SerologyGQX · Traditional	02/04/1986SE
K853067	Fiax Test Kit for Measles-G Antibodies FlyorescentGRE · Traditional	10/22/1985SE
K782041	Fiax Test KitDHN · Traditional	01/03/1979SE
K772114	Fiax C4 AssayDAK · Traditional	11/30/1977SE

Questions and answers

When was Fiax Test for Anti-Rubella Antibody cleared by the FDA?

Fiax Test for Anti-Rubella Antibody (K772219) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 46 days after the submission was received.

What is the product code of K772219?

The FDA product code is DHN – Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.