Cleared Traditional

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

K844066 is the FDA 510(k) clearance for COTROPIN STIMULATANEOUS 57 CO-LH 125I I... by Clinetics Corp.. It is a Class 1 Chemistry device (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

Submission Details

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.

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 K844066.
LEE-BEAD BETA FSH (EIA)
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PARAAMAX CHLORIDE DETERMINATION BY ISE
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AMERLEX-M FOLLICLE STIMULATING HORMONE(FSH)RADIOIM
K851361 · Amersham Corp. · May 1985
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