Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ANTI-N DNA ANTIBODY TEST KIT

K-Number: K832031 · 1983-08-11

ApplicantBreit Laboratories, Inc.
Decision Date1983-08-11
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI-N DNA ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Breit Laboratories, Inc.. It received FDA 510(k) clearance on 1983-08-11 under 510(k) number K832031. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-N DNA ANTIBODY TEST KIT?

ANTI-N DNA ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1983-08-11. The listed applicant is Breit Laboratories, Inc.. The 510(k) number is K832031.

When did ANTI-N DNA ANTIBODY TEST KIT receive FDA 510(k) clearance?

ANTI-N DNA ANTIBODY TEST KIT received FDA 510(k) clearance on 1983-08-11, under 510(k) number K832031.

Who is the listed applicant for ANTI-N DNA ANTIBODY TEST KIT?

The FDA 510(k) record lists Breit Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-N DNA ANTIBODY TEST KIT?

The FDA product code for ANTI-N DNA ANTIBODY TEST KIT is KTL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Breit Laboratories, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K851099IGM RHEUMATOID FACTOR TEST KITK840527COLOTRAK OCCULT BLOOD TESTK842137OCCULT BLOOD TESTK831927ANTINUCLEAR ANTIBODY TEST KIT

Related Devices (Code: KTL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑