Cleared Traditional

K883585 - TECHNICON ASSIST POTASSIUM

K883585 is an FDA 510(k) clearance for TECHNICON ASSIST POTASSIUM, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code CEJ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K883585 · Technicon Instruments Corp. · Chemistry device
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Nov 1988
Decision
98d
Days
Class 2
Risk

K883585 is an FDA 510(k) clearance for the TECHNICON ASSIST POTASSIUM. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 98 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 Technicon Instruments Corp. devices

FDA 510(k) Submission Details - K883585

510(k) Number K883585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date November 29, 1988
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEJ Device Classification - Class 2, Special Controls

Product Code CEJ Tetraphenyl Borate, Colorimetry, 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 - CEJ Tetraphenyl Borate, Colorimetry, Potassium

All 13
Devices cleared under the same product code (CEJ) and FDA review panel - the closest regulatory comparables to K883585.
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K881440 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1988
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