Cleared Traditional

K830624 - FLUOROMETER, GENERAL USE

K830624 is an FDA 510(k) clearance for FLUOROMETER, manufactured by Abbott Diagnostics. The device is a Class 1 Toxicology device with product code KHO cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K830624 · Abbott Diagnostics · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 1983
Decision
36d
Days
Class 1
Risk

K830624 is an FDA 510(k) clearance for the FLUOROMETER, GENERAL USE. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on April 5, 1983 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2560 - the FDA toxicology device 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 Abbott Diagnostics devices

FDA 510(k) Submission Details - K830624

510(k) Number K830624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1983
Decision Date April 05, 1983
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

KHO Device Classification - Class 1, General Controls

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 31
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K830624.
PFI-20 POLARIZING FLUORIMETER
K871550 · The Perkin-Elmer Corp. · Jul 1987
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · Lkb Instruments, Inc. · May 1985
INNOTRON FLUORIMETER SERIES ONE-10
K822942 · Innotron of Oregon, Inc. · Dec 1982
CLINISTAT TDA SERIES
K823112 · Miles Laboratories, Inc. · Nov 1982
MICROFLUOR READER
K822772 · Dynatech Corp. · Oct 1982