Cleared Traditional

K842444 - FSH RIA

K842444 is an FDA 510(k) clearance for FSH RIA, manufactured by Syncor Intl. Corp.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K842444 · Syncor Intl. Corp. · Chemistry device
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Aug 1984
Decision
57d
Days
Class 1
Risk

K842444 is an FDA 510(k) clearance for the FSH RIA. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Syncor Intl. Corp. (Mchenry, US). The FDA issued a Cleared decision on August 17, 1984 after a review of 57 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 Syncor Intl. Corp. devices

FDA 510(k) Submission Details - K842444

510(k) Number K842444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1984
Decision Date August 17, 1984
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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 54
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K842444.
LEE-BEAD BETA FSH (EIA)
K854837 · Leeco Diagnostics, Inc. · Jan 1986
PARAAMAX CHLORIDE DETERMINATION BY ISE
K854651 · American Dade · Dec 1985
AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · Amersham Corp. · May 1985
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