Cleared Traditional

K772073 - RADIAL IMMUNODIFFUSION KIT-COMP. 3

K772073 is the FDA 510(k) clearance for RADIAL IMMUNODIFFUSION KIT-COMP. 3 by Gelman Instrument Co.. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K772073 · Gelman Instrument Co. · Immunology device
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Feb 1978
Decision
92d
Days
Class 2
Risk

K772073 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION KIT-COMP. 3. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), 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 866.5240 - 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 K772073 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 DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K772073.
FIAX COMPLEMENT C4 TEST KIT
K830669 · Intl. Diagnostic Technology · Apr 1983
IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4
K812490 · Dako Corp. · Sep 1981
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K801361 · J.T. Baker Chemical Co. · Jun 1980
COMPLEMENT C4 NEPHELOMETRIC ASSAY
K772247 · Kallestad Laboratories, Inc. · Dec 1977
HUMAN C4 COMPLEMENT CONTROL SERUM
K772004 · G.D. Searle and Co. · Nov 1977
PLATES FOR HUMAN C4 COMPLEMENT
K772002 · G.D. Searle and Co. · Nov 1977