Cleared Traditional

K823379 - 125-I FSH RADIOIMMUNOASSAY KIT

K823379 is the FDA 510(k) clearance for 125-I FSH RADIOIMMUNOASSAY KIT by Clinetics Corp.. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K823379 · Clinetics Corp. · Chemistry device

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Dec 1982

Decision

40d

Days

Class 1

Risk

K823379 is an FDA 510(k) clearance for the 125-I FSH RADIOIMMUNOASSAY KIT. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Clinetics Corp. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - the FDA in vitro diagnostics and chemistry 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 Clinetics Corp. devices

Submission Details

510(k) Number	K823379 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 12, 1982
Decision Date	December 22, 1982
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

48d faster than avg

Panel avg: 88d · This submission: 40d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1300

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 54

Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K823379.

FSH QUIK RIA KIT

K840230 · Pacific Biotech, Inc. · Mar 1984

FSH RIA

K833852 · Syncor Intl. Corp. · Jan 1984

QUANTIMUNE HFSH RIA HUMAN FOLLICLE-

K831742 · Bio-Rad · Jul 1983

IMMO PHASE FSH RADIOIMMUNOASSAY

K822227 · Corning Medical & Scientific · Aug 1982

AMERLEX ESH KIT

K820754 · Amersham Corp. · Apr 1982

FOLLICLE STIMULATING HORMONE KIT

K820358 · Pcl-Ria, Inc. · Mar 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K823379

Clinetics Corp.

Mchenry, IL · US

Regulatory profile

9 submissions 9 cleared

100% clearance rate · Active in Chemistry

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Sourced from FDA 510(k) public files . Updated monthly.

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