Cleared Traditional

K800587 - NSI WASH SOLUTION CONCENTRATE

K800587 is the FDA 510(k) clearance for NSI WASH SOLUTION CONCENTRATE by Nobel Scientific Industries, Inc.. It is a Class 1 Chemistry device (product code JJC) cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K800587 · Nobel Scientific Industries, Inc. · Chemistry device
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Aug 1980
Decision
144d
Days
Class 1
Risk

K800587 is an FDA 510(k) clearance for the NSI WASH SOLUTION CONCENTRATE. Classified as Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (product code JJC), Class I - General Controls.

Submitted by Nobel Scientific Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1980 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2150 - 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 Nobel Scientific Industries, Inc. devices

Submission Details

510(k) Number K800587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1980
Decision Date August 08, 1980
Days to Decision 144 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d slower than avg
Panel avg: 88d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2150
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJC Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

All 21
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TECHNICON C800 SYSTEM
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