RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES— 510(k) K895995

Name: FDA 510(k) clearance K895995
Creator: U.S. Food and Drug Administration
Published: 1989-10-27

Substantially Equivalent

Lipogen, Inc.

FDA 510(k) clearance K895995 for RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES, Substantially Equivalent on 1989-10-27. Applicant: Lipogen, Inc.. Device class: 2.

Clearance details

Applicant: Lipogen, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1989-10-13
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

Download summary PDF View on FDA.gov ↗

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K902636 — LIPOGEN RHEUMELISA DSDNA ASSAY1990-06-28
K895996 — RHEUMELISA ASSAY FOR SM AUTOANTIBODIES1989-11-06
K895997 — RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES1989-11-06
K895994 — RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES1989-10-24
K894659 — ANA ANTISERA CONTROL KIT1989-09-21

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