Cleared Traditional

K832261 - GOAT ANTI-HUMAN LAMBA AFFINITY

K832261 is the FDA 510(k) clearance for GOAT ANTI-HUMAN LAMBA AFFINITY by Gelco Diagnostics, Inc.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K832261 · Gelco Diagnostics, Inc. · Immunology device
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Oct 1983
Decision
120d
Days
Class 2
Risk

K832261 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN LAMBA AFFINITY. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), 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 866.5550 - 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 K832261 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 DEH Lambda, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DEH Lambda, Antigen, Antiserum, Control

All 44
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K832261.
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT
K852999 · Kallestad Laboratories, Inc. · Oct 1985
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN
K842328 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT
K841864 · Kallestad Laboratories, Inc. · Jul 1984
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · Dako Corp. · Sep 1981
LAMBDA SERUM (FREE) ANTI-HUMAN
K781025 · Icl Scientific · Jul 1978
ANTI-HUMAN LAMBDA SERUM
K781220 · Icl Scientific · Jul 1978