Cleared Traditional

K834604 - C3 ANTISERUM CONTROL (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834604 · Technicon Instruments Corp. · Immunology device
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Jan 1984
Decision
116d
Days
Class 2
Risk

K834604 is an FDA 510(k) clearance for the C3 ANTISERUM CONTROL. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1984 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Technicon Instruments Corp. devices

Submission Details

510(k) Number K834604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1983
Decision Date January 24, 1984
Days to Decision 116 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 104d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.