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FDA 510(k)

AUTOFLUOR V SYSTEM

K-Number: K842991 · 1985-03-14

ApplicantTech America Diagnostics
Decision Date1985-03-14
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AUTOFLUOR V 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 1985-03-14 under 510(k) number K842991. 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 AUTOFLUOR V SYSTEM?

AUTOFLUOR V SYSTEM is a medical device that received FDA 510(k) clearance on 1985-03-14. The listed applicant is Tech America Diagnostics. The 510(k) number is K842991.

When did AUTOFLUOR V SYSTEM receive FDA 510(k) clearance?

AUTOFLUOR V SYSTEM received FDA 510(k) clearance on 1985-03-14, under 510(k) number K842991.

Who is the listed applicant for AUTOFLUOR V 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 AUTOFLUOR V SYSTEM?

The FDA product code for AUTOFLUOR V 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.

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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.

K841984AUTOFLOUR III 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.

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