LIPOGEN RHEUMELISA DSDNA ASSAY— 510(k) K902636

Substantially Equivalent

Lipogen, Inc.

FDA 510(k) clearance K902636 for LIPOGEN RHEUMELISA DSDNA ASSAY, Substantially Equivalent on 1990-06-28. Applicant: Lipogen, Inc.. Device class: 1.

Clearance details

Applicant: Lipogen, Inc.
Product code: Code LRY
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1990-06-14
Decision date: 1990-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Knoxville, TN, US

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Recent devices under product code LRY

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K895994 — RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIES1989-10-24
K894659 — ANA ANTISERA CONTROL KIT1989-09-21

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