Cleared Traditional

K933123 - SYNELISA TG ANTIBODIES/TPO ANTIBODIES

K933123 is an FDA 510(k) clearance for SYNELISA TG ANTIBODIES/TPO ANTIBODIES, manufactured by Elias U.S.A., Inc.. The device is a Class 1 Immunology device with product code JZS cleared through the Traditional 510(k) pathway after a 56-day FDA review.

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

FDA 510(k) Submission Details - K933123

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 105d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

JZS Device Classification - Class 1, General Controls

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.

Regulatory Peers - JZS Electrophoresis Instrumentation

Devices cleared under the same product code (JZS) and FDA review panel - the closest regulatory comparables to K933123.
IMMUNODIFFUSION BAND INTENSIFYING FLUID
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IMMUNOELECTROPHORESIS PROFILE KIT
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K770718 · Kallestad Laboratories, Inc. · Apr 1977
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K770719 · Kallestad Laboratories, Inc. · Apr 1977
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K770150 · Millipore Corp. · Feb 1977