Cleared Traditional

K772076 - RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.

K772076 is the FDA 510(k) clearance for RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB. by Gelman Instrument Co.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K772076 · Gelman Instrument Co. · Immunology device
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Feb 1978
Decision
92d
Days
Class 2
Risk

K772076 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978 after a review of 92 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 Gelman Instrument Co. devices

Submission Details

510(k) Number K772076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1977
Decision Date February 03, 1978
Days to Decision 92 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 faster than avg
Panel avg: 104d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, 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 - CZP Iga, Antigen, Antiserum, Control

All 45
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K772076.
LANCER L-INA ANTI-IGA
K791401 · Sherwood Medical Co. · Oct 1979
ANTISERUM, HUMAN, IGA
K790703 · Kent Laboratories, Inc. · Apr 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · Abbott Laboratories · Apr 1979
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · Kallestad Laboratories, Inc. · Dec 1977
IMMOCHEMISTRY SYSTEM
K771603 · Beckman Instruments, Inc. · Sep 1977
GOAT ANTISERUM IGA NEPHELOMETRIC
K770962 · Kallestad Laboratories, Inc. · Jun 1977