Cleared Traditional

K915690 - SLT 340 ATTC

K915690 is an FDA 510(k) clearance for SLT 340 ATTC, manufactured by Slt Labinstruments, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K915690 · Slt Labinstruments, Inc. · Chemistry device
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Apr 1992
Decision
121d
Days
Class 1
Risk

K915690 is an FDA 510(k) clearance for the SLT 340 ATTC. 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

FDA 510(k) Submission Details - K915690

510(k) Number K915690 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.

JJQ Device Classification - Class 1, General Controls

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.

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All 166
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