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FDA 510(k)

CAPPEL DIAGNOSTICS ANA KIT

K-Number: K862821 · 1986-08-15

ApplicantCappel Diagnostics, Inc.
Decision Date1986-08-15
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CAPPEL DIAGNOSTICS ANA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cappel Diagnostics, Inc.. It received FDA 510(k) clearance on 1986-08-15 under 510(k) number K862821. 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 CAPPEL DIAGNOSTICS ANA KIT?

CAPPEL DIAGNOSTICS ANA KIT is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is Cappel Diagnostics, Inc.. The 510(k) number is K862821.

When did CAPPEL DIAGNOSTICS ANA KIT receive FDA 510(k) clearance?

CAPPEL DIAGNOSTICS ANA KIT received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862821.

Who is the listed applicant for CAPPEL DIAGNOSTICS ANA KIT?

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

What is the FDA product code for CAPPEL DIAGNOSTICS ANA KIT?

The FDA product code for CAPPEL DIAGNOSTICS ANA KIT 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 Cappel Diagnostics, 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.

K872839ANTINUCLEAR ANTIBODY TESTK864275ANTI-NDNA ANTIBODY TEST KIT

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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