Cleared Traditional

K820048 - FSH RADIOIMMUNOASSAY TEST SYSTEM

K820048 is the FDA 510(k) clearance for FSH RADIOIMMUNOASSAY TEST SYSTEM by Monobind. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K820048 · Monobind · Chemistry device

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Feb 1982

Decision

27d

Days

Class 1

Risk

K820048 is an FDA 510(k) clearance for the FSH RADIOIMMUNOASSAY TEST SYSTEM. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Monobind (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982 after a review of 27 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 Monobind devices

Submission Details

510(k) Number	K820048 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 08, 1982
Decision Date	February 04, 1982
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

61d faster than avg

Panel avg: 88d · This submission: 27d

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 47

Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K820048.

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 DIRECT RIA

K811905 · Immunalysis Corporation · Jul 1981

LEECO FSH-QUANT DIAGNOSTIC KIT

K810663 · Leeco Diagnostics, Inc. · Mar 1981

HTSH RIABEAD DIAGNOSTIC KIT

K810381 · Abbott Laboratories · Feb 1981

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 K820048

Monobind

Mchenry, IL · US

Regulatory profile

21 submissions 21 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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

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