Cleared Traditional

K844066 - COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH

K844066 is an FDA 510(k) clearance for COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH, manufactured by Clinetics Corp.. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K844066 · Clinetics Corp. · Chemistry device
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Jan 1985
Decision
92d
Days
Class 1
Risk

K844066 is an FDA 510(k) clearance for the COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Clinetics Corp. (Tustin, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinetics Corp. devices

FDA 510(k) Submission Details - K844066

510(k) Number K844066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1984
Decision Date January 18, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 70
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K844066.
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 RIA
K842444 · Syncor Intl. Corp. · Aug 1984
FSH QUIK RIA KIT
K840230 · Pacific Biotech, Inc. · Mar 1984
RIANEN FOLLICLE STIMULATING HORMONE
K834038 · New England Nuclear · Jan 1984