Cleared Traditional

SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA (K821097) - FDA 510(k) Clearance

K821097 · Icl Scientific · Immunology device
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May 1982
Decision
15d
Days
-
Risk

K821097 is an FDA 510(k) clearance for the SYSTEMIC LUPUS ERYTHERMATOSUS ANTI-N-DNA.

Submitted by Icl Scientific (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel. 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.

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Submission Details

510(k) Number K821097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1982
Decision Date May 05, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 104d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -