Cleared Traditional

K822227 - IMMO PHASE FSH RADIOIMMUNOASSAY

K822227 is an FDA 510(k) clearance for IMMO PHASE FSH RADIOIMMUNOASSAY, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K822227 · Corning Medical & Scientific · Chemistry device

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Aug 1982

Decision

20d

Days

Class 1

Risk

K822227 is an FDA 510(k) clearance for the IMMO PHASE FSH RADIOIMMUNOASSAY. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 20 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.

FDA 510(k) Submission Details - K822227

510(k) Number	K822227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 27, 1982
Decision Date	August 16, 1982
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

69d faster than avg

Panel avg: 89d · This submission: 20d

Pathway characteristics

Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

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 86

Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K822227.

FSH RIA

K833852 · Syncor Intl. Corp. · Jan 1984

QUANTIMUNE HFSH RIA HUMAN FOLLICLE-

K831742 · Bio-Rad · Jul 1983

125-I FSH RADIOIMMUNOASSAY KIT

K823379 · Clinetics Corp. · Dec 1982

GAMMADAB [125] FSH RADIOIMMUNAY KIT

K821611 · Clinical Assays, Inc. · Jun 1982

AMERLEX ESH KIT

K820754 · Amersham Corp. · Apr 1982

MR1 FOLLITROPIN RIA KIT

K820740 · Microanalytic Research, Inc. · Apr 1982

FDA 510(k) Resources - Chemistry

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

Manufacturer of K822227

Corning Medical & Scientific

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

View all devices by Corning Medical & Scientific →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: August 16, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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