Cleared Traditional

K842313 - ELVI 146 SEROSCAN

K842313 is the FDA 510(k) clearance for ELVI 146 SEROSCAN by Logos Scientific, Inc.. It is a Class 1 Chemistry device (product code JQT) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K842313 · Logos Scientific, Inc. · Chemistry device
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Sep 1984
Decision
90d
Days
Class 1
Risk

K842313 is an FDA 510(k) clearance for the ELVI 146 SEROSCAN. Classified as Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT), Class I - General Controls.

Submitted by Logos Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 10, 1984 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2400 - 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 Logos Scientific, Inc. devices

Submission Details

510(k) Number K842313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date September 10, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2400
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 - JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica

All 9
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