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FDA 510(k)

ANTI N DNA-HCP

K-Number: K830652 · 1983-03-24

ApplicantImmuno-Products Industries
Decision Date1983-03-24
Product CodeKTL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANTI N DNA-HCP is the device name listed in this FDA 510(k) record. The listed applicant is Immuno-Products Industries. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830652. The device is classified under product code KTL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI N DNA-HCP?

ANTI N DNA-HCP is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Immuno-Products Industries. The 510(k) number is K830652.

When did ANTI N DNA-HCP receive FDA 510(k) clearance?

ANTI N DNA-HCP received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830652.

Who is the listed applicant for ANTI N DNA-HCP?

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

What is the FDA product code for ANTI N DNA-HCP?

The FDA product code for ANTI N DNA-HCP is KTL.

Other records listing Immuno-Products Industries 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.

K853122IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPEDK852230ANA/LITE-RL TEST SYSTEMK852231ANA/LITE-HEP-2 TEST SYSTEMK843613FLUORESCENT TREPONEMEL ANTIBODY-ABSORBK831054ANTINUCLEAR ANTIBODY TISSUE CULTURE SUBK821576ANTINUCLEAR ANTIBODY SCREEN FLOURESC

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Related Devices (Code: KTL)

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.

K231616ZEUS IFA(TM) nDNA Test System, ZEUS dIFineZeus ScientificK203599Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test SystemImmuno Concepts, N.A. , Ltd.K192916NOVA Lite DAPI dsDNA Crithidia luciliae KitInova Diagnostics, Inc.K172244EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K172252EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPatternEuroimmun Us, Inc.K011068RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100LRhigene, Inc.

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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