Cleared Traditional

FITC GOAT ANTI-HUMAN IGG Y CHAIN (K832264) - FDA 510(k) Clearance

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

K832264 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
120d
Days
Class 2
Risk

K832264 is an FDA 510(k) clearance for the FITC GOAT ANTI-HUMAN IGG Y CHAIN. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Gelco Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on October 28, 1983 after a review of 120 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 K832264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date October 28, 1983
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 104d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, 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 - DEW Igg, Antigen, Antiserum, Control

All 75
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K832264.
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K010617 · Helena Laboratories · Mar 2001
IGG
K983221 · Abbott Laboratories · Nov 1998
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · Beckman Instruments, Inc. · Mar 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · Beckman Instruments, Inc. · Mar 1997