Cleared Traditional

K772073 - RADIAL IMMUNODIFFUSION KIT-COMP. 3

K772073 is an FDA 510(k) clearance for RADIAL IMMUNODIFFUSION KIT-COMP. 3, manufactured by Gelman Instrument Co.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K772073

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
13d faster than avg
Panel avg: 105d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

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 29
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