FDA 510(k)

FANA 60

K-Number: K854314 · 1985-12-16

Decision Date1985-12-16

Product CodeDHN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

FANA 60 is the device name listed in this FDA 510(k) record. The listed applicant is American Bio-Reagents, Inc.. It received FDA 510(k) clearance on 1985-12-16 under 510(k) number K854314. 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 FANA 60?

FANA 60 is a medical device that received FDA 510(k) clearance on 1985-12-16. The listed applicant is American Bio-Reagents, Inc.. The 510(k) number is K854314.

When did FANA 60 receive FDA 510(k) clearance?

FANA 60 received FDA 510(k) clearance on 1985-12-16, under 510(k) number K854314.

Who is the listed applicant for FANA 60?

The FDA 510(k) record lists American Bio-Reagents, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FANA 60?

The FDA product code for FANA 60 is DHN.

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.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

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