Cleared Traditional

K840887 - AMRESCO E2A REAGENT SET 0562 & 0626

K840887 is the FDA 510(k) clearance for AMRESCO E2A REAGENT SET 0562 & 0626 by American Research Products Co.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K840887 · American Research Products Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1984
Decision
51d
Days
Class 2
Risk

K840887 is an FDA 510(k) clearance for the AMRESCO E2A REAGENT SET 0562 & 0626. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1984 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 K840887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1984
Decision Date April 18, 1984
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CEM Electrode, Ion Specific, Potassium

All 56
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K840887.
LYTETEK 1000 NA/K SODIUM/POTASSIUM ANALYZER
K844044 · Medica Corp. · Nov 1984
DACOS PLUS LYTES OPTION
K843239 · Coulter Electronics, Inc. · Oct 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · American Monitor Corp. · Sep 1984
ACID BASE LABORATORY ABL4
K833696 · Radiometer America, Inc. · Jan 1984
QEA SODIUM/POTASSIUM ANALYZER
K833776 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1983
POTASSIUM ELECTRODE TIP ASSAMBLY-K-
K833159 · Hi Chem, Inc. · Nov 1983