Cleared Traditional

LIPOGEN RHEUMELISA DSDNA ASSAY (K902636) - FDA 510(k) Clearance

Class I Immunology device.

K902636 · Lipogen, Inc. · Immunology device
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Jun 1990
Decision
14d
Days
Class 1
Risk

K902636 is an FDA 510(k) clearance for the LIPOGEN RHEUMELISA DSDNA ASSAY. Classified as Punch, Surgical (product code LRY), Class I - General Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on June 28, 1990 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 878.4800 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lipogen, Inc. devices

Submission Details

510(k) Number K902636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1990
Decision Date June 28, 1990
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 104d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRY Punch, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.