Cleared Traditional

K834038 - RIANEN FOLLICLE STIMULATING HORMONE

K834038 is the FDA 510(k) clearance for RIANEN FOLLICLE STIMULATING HORMONE by New England Nuclear. It is a Class 1 Chemistry device (product code CGJ) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K834038 · New England Nuclear · Chemistry device
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Jan 1984
Decision
68d
Days
Class 1
Risk

K834038 is an FDA 510(k) clearance for the RIANEN FOLLICLE STIMULATING HORMONE. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by New England Nuclear (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 68 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 New England Nuclear devices

Submission Details

510(k) Number K834038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1983
Decision Date January 30, 1984
Days to Decision 68 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 88d · This submission: 68d
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 K834038.
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · Amersham Corp. · May 1985
FSH RIA
K842444 · Syncor Intl. Corp. · Aug 1984
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