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FDA 510(k)

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES

K-Number: K895997 · 1989-11-06

ApplicantLipogen, Inc.
Decision Date1989-11-06
Product CodeLKO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

RHEUMELISA ASSAY FOR RNP 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 1989-11-06 under 510(k) number K895997. The device is classified under product code LKO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES?

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES is a medical device that received FDA 510(k) clearance on 1989-11-06. The listed applicant is Lipogen, Inc.. The 510(k) number is K895997.

When did RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES receive FDA 510(k) clearance?

RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895997.

Who is the listed applicant for RHEUMELISA ASSAY FOR RNP 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 RNP AUTOANTIBODIES?

The FDA product code for RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES is LKO.

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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 ASSAYK895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESK895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESK895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESK894659ANA ANTISERA CONTROL KITK892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST

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Related Devices (Code: LKO)

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.

K191085Maverick RNP Assay and Maverick Diagnostic SystemGenalyte, Inc.K123261EUROIMMUN ANTI-NRNP/SM ELISA (IGG)Euroimmun USK083117ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01Phadia US, Inc.K071210MODIFICATION TO FIDIS CONNECTIVE 10*, MODEL MX006Biomedical Diagnostics (Bmd) SAK022017RHIGENE MESACUP-2 TEST RNP, MODEL M7741Rhigene, Inc.K000752RHIGENE MESACUP2 TEST- RNPRhigene, 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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