Cleared Traditional

K851984 - LKB-WALLAC 1230 ARCUS FLUOROMETER

K851984 is the FDA 510(k) clearance for LKB-WALLAC 1230 ARCUS FLUOROMETER by Lkb Instruments, Inc.. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K851984 · Lkb Instruments, Inc. · Chemistry device
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May 1985
Decision
17d
Days
Class 1
Risk

K851984 is an FDA 510(k) clearance for the LKB-WALLAC 1230 ARCUS FLUOROMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Lkb Instruments, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on May 24, 1985 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2560 - 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 K851984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1985
Decision Date May 24, 1985
Days to Decision 17 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 88d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KHO Fluorometer, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2560
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 - KHO Fluorometer, For Clinical Use

All 24
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K851984.
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989
PFI-20 POLARIZING FLUORIMETER
K871550 · The Perkin-Elmer Corp. · Jul 1987
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
CLINISTAT TDA SERIES
K823112 · Miles Laboratories, Inc. · Nov 1982
FLUOROSTAT FLUOROMETER
K822701 · Miles Laboratories, Inc. · Oct 1982
A FLUOROMETER
K813540 · American Diagnostic Corp. · Dec 1981