Cleared Traditional

K840961 - ESCHWEILER COMBI-ANALYSER MTA-500

K840961 is an FDA 510(k) clearance for ESCHWEILER COMBI-ANALYSER MTA-500, manufactured by U.S. Science, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K840961 · U.S. Science, Inc. · Chemistry device
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Aug 1984
Decision
157d
Days
Class 2
Risk

K840961 is an FDA 510(k) clearance for the ESCHWEILER COMBI-ANALYSER MTA-500. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by U.S. Science, Inc. (Walker, US). The FDA issued a Cleared decision on August 10, 1984 after a review of 157 days - an extended review 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: 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 U.S. Science, Inc. devices

FDA 510(k) Submission Details - K840961

510(k) Number K840961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date August 10, 1984
Days to Decision 157 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 88d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K840961.
DACOS PLUS LYTES OPTION
K843239 · Coulter Electronics, Inc. · Oct 1984
DYNA-LYTE 2000
K842786 · Abbott Diagnostics · Sep 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · American Monitor Corp. · Sep 1984
AMRESCO E2A REAGENT SET 0562 & 0626
K840887 · American Research Products Co. · Apr 1984
ACID BASE LABORATORY ABL4
K833696 · Radiometer America, Inc. · Jan 1984
QEA SODIUM/POTASSIUM ANALYZER
K833776 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1983