Cleared Traditional

K854094 - IMMUCHEM COVALENT COAT A SOLID PHASE RA...

K854094 is the FDA 510(k) clearance for IMMUCHEM COVALENT COAT A SOLID PHASE RA... by Immuchem Corp.. It is a Class 1 Chemistry device (product code JLS) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K854094 · Immuchem Corp. · Chemistry device
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Feb 1986
Decision
144d
Days
Class 1
Risk

K854094 is an FDA 510(k) clearance for the IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS. Classified as Radioimmunoassay, Progesterone (product code JLS), Class I - General Controls.

Submitted by Immuchem Corp. (Carson, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1620 - 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 Immuchem Corp. devices

Submission Details

510(k) Number K854094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1985
Decision Date February 28, 1986
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 88d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLS Radioimmunoassay, Progesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1620
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 - JLS Radioimmunoassay, Progesterone

All 33
Devices cleared under the same product code (JLS) and FDA review panel - the closest regulatory comparables to K854094.
AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144
K884100 · Amersham Corp. · Nov 1988
MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT
K880934 · Amersham Corp. · Apr 1988
AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT
K864855 · Amersham Corp. · Feb 1987
DSL ANDROSTENEDIONE RIA (DSL #4200)
K854675 · Diagnostic Systems Laboratories, Inc. · Jan 1986
DSL PROGESTERONE RIA (DSL #3400)
K854649 · Diagnostic Systems Laboratories, Inc. · Dec 1985
LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT
K850056 · Leeco Diagnostics, Inc. · Feb 1985