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FDA 510(k)

LIPOGEN RHEUMELISA DSDNA ASSAY

K-Number: K902636 · 1990-06-28

ApplicantLipogen, Inc.
Decision Date1990-06-28
Product CodeLRY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIPOGEN RHEUMELISA DSDNA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Lipogen, Inc.. It received FDA 510(k) clearance on 1990-06-28 under 510(k) number K902636. The device is classified under product code LRY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPOGEN RHEUMELISA DSDNA ASSAY?

LIPOGEN RHEUMELISA DSDNA ASSAY is a medical device that received FDA 510(k) clearance on 1990-06-28. The listed applicant is Lipogen, Inc.. The 510(k) number is K902636.

When did LIPOGEN RHEUMELISA DSDNA ASSAY receive FDA 510(k) clearance?

LIPOGEN RHEUMELISA DSDNA ASSAY received FDA 510(k) clearance on 1990-06-28, under 510(k) number K902636.

Who is the listed applicant for LIPOGEN RHEUMELISA DSDNA ASSAY?

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 LIPOGEN RHEUMELISA DSDNA ASSAY?

The FDA product code for LIPOGEN RHEUMELISA DSDNA ASSAY is LRY.

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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.

K895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESK895996RHEUMELISA 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: LRY)

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.

K933516ACU-E PUNCHAcuderm, Inc.K904869ELLIPSE PUNCHKramer ConstK896303BIOPSY PUNCHPremier MedicalK874356PIN PUNCHMed-Tool, Inc.K874357TAPERED PUNCHMed-Tool, Inc.K872388NAIL SETMed-Tool, 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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