Cleared Traditional

SYNELISA TG ANTIBODIES/TPO ANTIBODIES (K933123) - FDA 510(k) Clearance

Class I Immunology device.

K933123 · Elias U.S.A., Inc. · Immunology device
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Aug 1993
Decision
56d
Days
Class 1
Risk

K933123 is an FDA 510(k) clearance for the SYNELISA TG ANTIBODIES/TPO ANTIBODIES. Classified as Electrophoresis Instrumentation (product code JZS), Class I - General Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.4500 - 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 Elias U.S.A., Inc. devices

Submission Details

510(k) Number K933123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1993
Decision Date August 23, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 104d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JZS Electrophoresis Instrumentation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.4500
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.