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)

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS

K-Number: K872085 · 1987-09-01

ApplicantImmunodiagnostics, Ltd.
Decision Date1987-09-01
Product CodeLSW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Immunodiagnostics, Ltd.. It received FDA 510(k) clearance on 1987-09-01 under 510(k) number K872085. The device is classified under product code LSW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS?

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS is a medical device that received FDA 510(k) clearance on 1987-09-01. The listed applicant is Immunodiagnostics, Ltd.. The 510(k) number is K872085.

When did THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS receive FDA 510(k) clearance?

THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS received FDA 510(k) clearance on 1987-09-01, under 510(k) number K872085.

Who is the listed applicant for THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS?

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

What is the FDA product code for THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS?

The FDA product code for THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS is LSW.

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

Related Devices (Code: LSW)

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.

K172348AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10Aesku.Diagnostics GmbH & Co. KGK152013QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsInova Diagnostics, Inc.K081251MODIFICATION TO AESKULISA DS DNA GAesku DiagnosticsK072393ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01Phadia US, Inc.K060380FIDIS DSDNABiomedical Diagnostics (Bmd) SAK041628AESKULISA DS DNA GAesku Diagnostics

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.

↑