Cleared Traditional

K861194 - ULTROSPEC K KINETICS SPECTROPHOTOMETER (FDA 510(k) Clearance)

Class I Chemistry device.

K861194 · Lkb Instruments, Inc. · Chemistry device
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Apr 1986
Decision
24d
Days
Class 1
Risk

K861194 is an FDA 510(k) clearance for the ULTROSPEC K KINETICS SPECTROPHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on April 24, 1986 after a review of 24 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lkb Instruments, Inc. devices

Submission Details

510(k) Number K861194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1986
Decision Date April 24, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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.