NDNA ANTIBODY TEST KIT— 510(k) K874191

Substantially Equivalent

Lipogen, Inc.

FDA 510(k) clearance K874191 for NDNA ANTIBODY TEST KIT, Substantially Equivalent on 1987-12-18. Applicant: Lipogen, Inc.. Device class: 2.

Clearance details

Applicant: Lipogen, Inc.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1987-10-14
Decision date: 1987-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

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More clearances from Lipogen, Inc.

K902636 — LIPOGEN RHEUMELISA DSDNA ASSAY1990-06-28
K895996 — RHEUMELISA ASSAY FOR SM AUTOANTIBODIES1989-11-06
K895997 — RHEUMELISA ASSAY FOR RNP AUTOANTIBODIES1989-11-06
K895995 — RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES1989-10-27
K895994 — RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES1989-10-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.