Cleared Traditional

K842786 - DYNA-LYTE 2000

K842786 is an FDA 510(k) clearance for DYNA-LYTE 2000, manufactured by Abbott Diagnostics. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K842786 · Abbott Diagnostics · Chemistry device
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Sep 1984
Decision
115d
Days
Class 2
Risk

K842786 is an FDA 510(k) clearance for the DYNA-LYTE 2000. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 115 days - within the typical 510(k) review window.

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 Abbott Diagnostics devices

FDA 510(k) Submission Details - K842786

510(k) Number K842786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1984
Decision Date September 14, 1984
Days to Decision 115 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
27d slower than avg
Panel avg: 88d · This submission: 115d
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 69
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K842786.
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