Cleared Traditional

K772183 - THYROID BINDING GLOBULIN

K772183 is an FDA 510(k) clearance for THYROID BINDING GLOBULIN, manufactured by Corning Medical & Scientific. The device is a Class 2 Immunology device with product code CEE cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K772183 · Corning Medical & Scientific · Immunology device
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Dec 1977
Decision
25d
Days
Class 2
Risk

K772183 is an FDA 510(k) clearance for the THYROID BINDING GLOBULIN. Classified as Radioimmunoassay, Thyroxine-binding Globulin (product code CEE), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1685 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Corning Medical & Scientific devices

FDA 510(k) Submission Details - K772183

510(k) Number K772183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1977
Decision Date December 20, 1977
Days to Decision 25 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
80d faster than avg
Panel avg: 105d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEE Device Classification - Class 2, Special Controls

Product Code CEE Radioimmunoassay, Thyroxine-binding Globulin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1685
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 - CEE Radioimmunoassay, Thyroxine-binding Globulin

All 22
Devices cleared under the same product code (CEE) and FDA review panel - the closest regulatory comparables to K772183.
RIA PHASE TBG
K800204 · Boehringer Mannheim Corp. · Mar 1980
GLOBULIN TEST, HUMAN THYROXINE BINDING
K781225 · Hyland Therapeutic Div., Travenol Laboratories · Aug 1978
STIKSEP-T3 KIT
K780486 · Nuclear Diagnostics, Inc. · Apr 1978
SPINSEP-TBG
K771341 · Nuclear Diagnostics, Inc. · Aug 1977
PROCEDURE, RA, THYROXINE BINDING PROTEIN
K760134 · Bio-Rad · Jul 1976