Fiax Test Kit for Varicella Antibody Serology

FDA 510(k) K853540 · Idt, A Division of Whittaker M.A. Bioproducts

Substantially Equivalent

510(k) numberK853540

Submission

Device name
Fiax Test Kit for Varicella Antibody Serology
Applicant
Idt, A Division of Whittaker M.A. Bioproducts
San Jose, CA, US
Received
August 23, 1985
Decision date
February 4, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GQX – Antiserum, Cf, Varicella-Zoster
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3900
Specialty
Microbiology

Other 510(k)s with product code GQX

510(k)DeviceApplicantDecision
K951799Varicella-Zoster Virus Direct Immunofluorescence AssayGQX · Traditional Light Diagnostics03/20/1996SE
K911301VZV Igm TestGQX · Traditional Gull Laboratories, Inc.07/17/1991SE
K883427Virgo(R) Vzv-Igg ElisaGQX · Traditional Electro-Nucleonics, Inc.03/10/1989SE
K875358VZV TestGQX · Traditional Gull Laboratories, Inc.03/31/1988SE
K863317Enzygnost Anti-Vzv Igg TestGQX · Traditional Behring Diagnostics, Inc.04/22/1987SE
K852930Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional Microbix Biosystems, Inc.11/12/1985SE
K842096GLB Varicella-Zoster Virus FluorescentGQX · Traditional Great Lakes Bioscience01/07/1985SE
K841526Ortho Varicella-Zoster Virus Ident.GQX · Traditional Ortho Diagnostic Systems, Inc.06/25/1984SE
K770810Varicella-Zoster Fa Labeled PreserumGQX · Traditional Flow Laboratories, Inc.05/20/1977SE
K770806Varicella-Zoster Fa Labelled (8-321 RF)GQX · Traditional Flow Laboratories, Inc.05/20/1977SE

More from Flow Laboratories, Inc.

510(k)DeviceDecision
K853067Fiax Test Kit for Measles-G Antibodies FlyorescentGRE · Traditional 10/22/1985SE
K782041Fiax Test KitDHN · Traditional 01/03/1979SE
K772219Fiax Test for Anti-Rubella AntibodyDHN · Traditional 01/20/1978SE
K772114Fiax C4 AssayDAK · Traditional 11/30/1977SE

Questions and answers

When was Fiax Test Kit for Varicella Antibody Serology cleared by the FDA?

Fiax Test Kit for Varicella Antibody Serology (K853540) received a 510(k) decision of Substantially Equivalent on February 4, 1986, 165 days after the submission was received.

What is the product code of K853540?

The FDA product code is GQX – Antiserum, Cf, Varicella-Zoster, a Class II (moderate risk) device regulated under 21 CFR 866.3900.