Anti-N DNA Antibody Test Kit

Q: What is the product code of K832031?

The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.

FDA 510(k) K832031 · Breit Laboratories, Inc.

Substantially Equivalent

510(k) numberK832031

Submission

Device name: Anti-N DNA Antibody Test Kit
Applicant: Breit Laboratories, Inc.
Mchenry, IL, US
Received: June 23, 1983
Decision date: August 11, 1983
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: KTL – Anti-Dna Indirect Immunofluorescent Solid Phase
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.5100
Specialty: Immunology

Other 510(k)s with product code KTL

510(k)	Device	Applicant	Decision
K231616	ZEUS IFA(TM) nDNA Test System, ZEUS dIFineKTL · Traditional	Zeus Scientific	08/31/2023SE
K203599	Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemKTL · Traditional	Immuno Concepts, N.A. , Ltd.	05/26/2023SE
K192916	NOVA Lite DAPI dsDNA Crithidia luciliae KitKTL · Traditional	Inova Diagnostics, Inc.	12/11/2020SE
K172252	EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternKTL · Traditional	Euroimmun Us, Inc.	04/20/2018SE
K172244	EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternKTL · Traditional	Euroimmun Us, Inc.	04/20/2018SE
K011068	Rhigene Ndna Test System for Imagetiter, Model CL100LKTL · Traditional	Rhigene, Inc.	04/11/2002SE
K013432	Igg Anti-Ndna Fluorescent Test System; Model # 3040GKTL · Traditional	Immuno Concepts, Inc.	11/29/2001SE
K990916	Indirect Fluorescence Assay for Anti-Native DNA Igg AntibodyKTL · Traditional	Stellar Bio Systems, Inc.	04/21/1999SE
K930987	Crithidia Lucilliae DS DNA Kit (Diagnostic Use)KTL · Traditional	The Binding Site, Ltd.	08/10/1993SE
K905386	Distat Anti-Dsdna KitKTL · Traditional	Shield Diagnostics, Ltd.	12/13/1990SE

More from Shield Diagnostics, Ltd.

510(k)	Device	Decision
K851099	Igm Rheumatoid Factor Test KitDHR · Traditional	04/25/1985SE
K842137	Occult Blood TestKHE · Traditional	09/05/1984SE
K840527	Colotrak Occult Blood TestKHE · Traditional	09/05/1984SE
K831927	Antinuclear Antibody Test KitDAA · Traditional	07/18/1983SE

Questions and answers

When was Anti-N DNA Antibody Test Kit cleared by the FDA?

Anti-N DNA Antibody Test Kit (K832031) received a 510(k) decision of Substantially Equivalent on August 11, 1983, 49 days after the submission was received.

What is the product code of K832031?

The FDA product code is KTL – Anti-Dna Indirect Immunofluorescent Solid Phase, a Class II (moderate risk) device regulated under 21 CFR 866.5100.