Cleared Traditional

AMRESCO E4A REAGENT SET (K840868) - FDA 510(k) Clearance

Class I Chemistry device.

K840868 · American Research Products Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1984
Decision
85d
Days
Class 1
Risk

K840868 is an FDA 510(k) clearance for the AMRESCO E4A REAGENT SET. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 American Research Products Co. devices

Submission Details

510(k) Number K840868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date May 22, 1984
Days to Decision 85 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 88d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 77
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K840868.
ADD-1
K844114 · Abbott Laboratories · Nov 1984
BOEHRINGER MANNHEIM DIAGNOSTICS ADAM
K843283 · Boehringer Mannheim Corp. · Oct 1984
ABBOTT PROJECT I
K841916 · Abbott Laboratories · Jun 1984
KODAK EKTACHEM DT 60 ANALYZER
K841503 · Eastman Kodak Company · May 1984
DISCRETE CLINICAL ANALYZER
K834521 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1984
KODAK EKTACHEM 700 ANALYZER
K833833 · Eastman Kodak Company · Jan 1984