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FDA 510(k)

ANA APPLELISA

K-Number: K834241 · 1984-04-04

ApplicantApple Diagnostic Products
Decision Date1984-04-04
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA APPLELISA is the device name listed in this FDA 510(k) record. The listed applicant is Apple Diagnostic Products. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K834241. 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 ANA APPLELISA?

ANA APPLELISA is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Apple Diagnostic Products. The 510(k) number is K834241.

When did ANA APPLELISA receive FDA 510(k) clearance?

ANA APPLELISA received FDA 510(k) clearance on 1984-04-04, under 510(k) number K834241.

Who is the listed applicant for ANA APPLELISA?

The FDA 510(k) record lists Apple Diagnostic Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANA APPLELISA?

The FDA product code for ANA APPLELISA is DHN.

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Other records listing Apple Diagnostic Products 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.

K844287ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDIIK843745ADP ANA APPLEZYMEK843120APPLELISA CHLAMYDIA TRACHOMATIS ANTIK842707ADP NDNA IFA TESTK842183ADP ANA IFA TESTK834242ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS

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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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