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FDA 510(k)

HISTONES EIA DIAGNOSTIC KIT

K-Number: K870458 · 1987-03-17

ApplicantBiohytech International, Inc.
Decision Date1987-03-17
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

HISTONES EIA DIAGNOSTIC KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biohytech International, Inc.. It received FDA 510(k) clearance on 1987-03-17 under 510(k) number K870458. 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 HISTONES EIA DIAGNOSTIC KIT?

HISTONES EIA DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1987-03-17. The listed applicant is Biohytech International, Inc.. The 510(k) number is K870458.

When did HISTONES EIA DIAGNOSTIC KIT receive FDA 510(k) clearance?

HISTONES EIA DIAGNOSTIC KIT received FDA 510(k) clearance on 1987-03-17, under 510(k) number K870458.

Who is the listed applicant for HISTONES EIA DIAGNOSTIC KIT?

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

What is the FDA product code for HISTONES EIA DIAGNOSTIC KIT?

The FDA product code for HISTONES EIA DIAGNOSTIC KIT is DHN.

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Other records listing Biohytech International, Inc. 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.

K870453DS-DNA EIA DIAGNOSTIC KITK870452SS-DNA EIA DIAGNOSTIC KITK870457RNP EIA DIAGNOSTIC KITK870455SM EIA DIAGNOSTIC KITK870456DNP EIA DIAGNOSTIC KITK862969ANA-ENZYME IMMUNOASSAY (ANA-EIA) DIAGNOSTIC KIT

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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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