Cleared Traditional

K832262 - FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS

K832262 is the FDA 510(k) clearance for FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS by Gelco Diagnostics, Inc.. It is a Class 2 Immunology device (product code CZN) cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K832262 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
123d
Days
Class 2
Risk

K832262 is an FDA 510(k) clearance for the FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS. Classified as Iga, Fitc, Antigen, Antiserum, Control (product code CZN), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 31, 1983 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 Gelco Diagnostics, Inc. devices

Submission Details

510(k) Number K832262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 31, 1983
Days to Decision 123 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 104d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZN Iga, Fitc, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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.

Regulatory Peers - CZN Iga, Fitc, Antigen, Antiserum, Control

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