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FDA 510(k)

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES

K-Number: K895994 · 1989-10-24

ApplicantLipogen, Inc.
Decision Date1989-10-24
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES is the device name listed in this FDA 510(k) record. The listed applicant is Lipogen, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K895994. 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 RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES?

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Lipogen, Inc.. The 510(k) number is K895994.

When did RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES receive FDA 510(k) clearance?

RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895994.

Who is the listed applicant for RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES?

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

What is the FDA product code for RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES?

The FDA product code for RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES is LJM.

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Other records listing Lipogen, 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.

K902636LIPOGEN RHEUMELISA DSDNA ASSAYK895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESK895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESK895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESK894659ANA ANTISERA CONTROL KITK892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

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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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