Cleared Traditional

K915689 - SLT SPECTRA

K915689 is the FDA 510(k) clearance for SLT SPECTRA by Slt Labinstruments, Inc.. It is a Class 1 Chemistry device (product code JJQ) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K915689 · Slt Labinstruments, Inc. · Chemistry device
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Apr 1992
Decision
121d
Days
Class 1
Risk

K915689 is an FDA 510(k) clearance for the SLT SPECTRA. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Slt Labinstruments, Inc. (Research Triangle Park, US). The FDA issued a Cleared decision on April 22, 1992 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - 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 Slt Labinstruments, Inc. devices

Submission Details

510(k) Number K915689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date April 22, 1992
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 135
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