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)

AUTOFLOUR III SYSTEM

K-Number: K841984 · 1984-11-01

ApplicantTech America Diagnostics
Decision Date1984-11-01
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOFLOUR III SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tech America Diagnostics. It received FDA 510(k) clearance on 1984-11-01 under 510(k) number K841984. 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 AUTOFLOUR III SYSTEM?

AUTOFLOUR III SYSTEM is a medical device that received FDA 510(k) clearance on 1984-11-01. The listed applicant is Tech America Diagnostics. The 510(k) number is K841984.

When did AUTOFLOUR III SYSTEM receive FDA 510(k) clearance?

AUTOFLOUR III SYSTEM received FDA 510(k) clearance on 1984-11-01, under 510(k) number K841984.

Who is the listed applicant for AUTOFLOUR III SYSTEM?

The FDA 510(k) record lists Tech America Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOFLOUR III SYSTEM?

The FDA product code for AUTOFLOUR III SYSTEM 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_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 Tech America Diagnostics 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.

K842991AUTOFLUOR V SYSTEMK843181AUTOFLUOR IV SYSTEM

Related Devices (Code: DHN)

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.

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.KgK160265Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K120889AESKUSLIDES ANA HEP-2Aesku DiagnosticsK070763EUROIMMUN 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.

↑