Cleared Traditional

K832261 - GOAT ANTI-HUMAN LAMBA AFFINITY

K832261 is an FDA 510(k) clearance for GOAT ANTI-HUMAN LAMBA AFFINITY, manufactured by Gelco Diagnostics, Inc.. The device is a Class 2 Immunology device with 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.

FDA 510(k) Submission Details - K832261

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 105d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEH Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K832261.
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
GOAT ANTI-HUMAN LAMBA
K832270 · Gelco Diagnostics, Inc. · Oct 1983
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
K832261 · GOAT ANTI-HUMAN LAMBA AFFINITY
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