Cleared Traditional

K843008 - ION SELECTIVE ELECTRODES & REAGENT SYS

K843008 is the FDA 510(k) clearance for ION SELECTIVE ELECTRODES & REAGENT SYS by American Monitor Corp.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K843008 · American Monitor Corp. · Chemistry device
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Sep 1984
Decision
35d
Days
Class 2
Risk

K843008 is an FDA 510(k) clearance for the ION SELECTIVE ELECTRODES & REAGENT SYS. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 35 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 Monitor Corp. devices

Submission Details

510(k) Number K843008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1984
Decision Date September 04, 1984
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 54
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K843008.
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