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FDA 510(k)

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES

K-Number: K895996 · 1989-11-06

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

Device Summary

RHEUMELISA ASSAY FOR SM 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 K895996. The device is classified under product code LKP. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RHEUMELISA ASSAY FOR SM AUTOANTIBODIES?

RHEUMELISA ASSAY FOR SM 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 K895996.

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

RHEUMELISA ASSAY FOR SM AUTOANTIBODIES received FDA 510(k) clearance on 1989-11-06, under 510(k) number K895996.

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

The FDA product code for RHEUMELISA ASSAY FOR SM AUTOANTIBODIES is LKP.

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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 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: LKP)

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.

K202067EliA SmDP-SPhadia ABK183007EliA SmDP ImmunoassayPhadia ABK123593QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS,Inova Diagnostics, Inc.K051066THERATEST EL-ANA PROFILESTheratest Laboratories, Inc.K042629VARELISA SM ANTIBODIES, MODEL 18296Sweden Diagnostics (Germany) GmbHK024219LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115Bio-Rad

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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