FDA 510(k)

SERA FOR ANTINUCLEAR ANTIBODIES

K-Number: K820945 · 1982-10-26

ApplicantCenters for Disease Control and Prevention

Decision Date1982-10-26

Product CodeDHN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

SERA FOR ANTINUCLEAR ANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 1982-10-26 under 510(k) number K820945. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERA FOR ANTINUCLEAR ANTIBODIES?

SERA FOR ANTINUCLEAR ANTIBODIES is a medical device that received FDA 510(k) clearance on 1982-10-26. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K820945.

When did SERA FOR ANTINUCLEAR ANTIBODIES receive FDA 510(k) clearance?

SERA FOR ANTINUCLEAR ANTIBODIES received FDA 510(k) clearance on 1982-10-26, under 510(k) number K820945.

Who is the listed applicant for SERA FOR ANTINUCLEAR ANTIBODIES?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERA FOR ANTINUCLEAR ANTIBODIES?

The FDA product code for SERA FOR ANTINUCLEAR ANTIBODIES is DHN.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Centers for Disease Control and Prevention as applicant

K260812Francisella tularensis Real-time PCR Assay K252072Francisella tularensis Real-time PCR assay K243274CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K243931CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A Subtyping Kit (VER 4); Influenza B Lineage Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)K241110CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)K222558Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

View all 23 devices →

Related Devices (Code: DHN)

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc.K172745ImmuGlo HEp-2 Elite IFAImmco Diagnostics, Inc.K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEMAesku Systems GmbH&Co.Kg K160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku Diagnostics K070763EUROIMMUN ANA IFA: HEP-20-10Euroimmun Us, LLC

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.