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FDA 510(k)

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA

K-Number: K041102 · 2004-10-26

ApplicantImmco Diagnostics, Inc.
Decision Date2004-10-26
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Immco Diagnostics, Inc.. It received FDA 510(k) clearance on 2004-10-26 under 510(k) number K041102. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA?

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA is a medical device that received FDA 510(k) clearance on 2004-10-26. The listed applicant is Immco Diagnostics, Inc.. The 510(k) number is K041102.

When did IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA receive FDA 510(k) clearance?

IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA received FDA 510(k) clearance on 2004-10-26, under 510(k) number K041102.

Who is the listed applicant for IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA?

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

What is the FDA product code for IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA?

The FDA product code for IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA is LJM.

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Other records listing Immco Diagnostics, Inc. as applicant

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Related Devices (Code: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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.

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