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FDA 510(k)

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM

K-Number: K980337 · 1998-05-12

ApplicantHelix Diagnostics, Inc.
Decision Date1998-05-12
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Helix Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-05-12 under 510(k) number K980337. 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 DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM?

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-12. The listed applicant is Helix Diagnostics, Inc.. The 510(k) number is K980337.

When did DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM receive FDA 510(k) clearance?

DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM received FDA 510(k) clearance on 1998-05-12, under 510(k) number K980337.

Who is the listed applicant for DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM?

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

What is the FDA product code for DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM?

The FDA product code for DIAMEDIX IMMUNOSIMPLICITY ANA (IS-ANA) SCREEN TEST SYSTEM is LJM.

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Other records listing Helix 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.

K001900ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TESTK000489ENZYME IMMUNOASSAY ANTI-CENTROMERE ANTIBODY TESTK960091ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KITK954723ENZYME IMMUNOASSAY ANA SCREENING TEST KITK954700ENZYME IMMUNOASSAY LUPUS SCREEN TEST KITK952253ENZYME IMMUNOASSAY ENA PLUS SCREENING TEST KIT

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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

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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