Cleared Traditional

K802579 - CYBREX TM FPQ FLUORESCENE POLARIZATION

K802579 is an FDA 510(k) clearance for CYBREX TM FPQ FLUORESCENE POLARIZATION, manufactured by Abbott Laboratories. The device is a Class 1 Pathology device with product code KHO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K802579 · Abbott Laboratories · Pathology device
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Nov 1980
Decision
23d
Days
Class 1
Risk

K802579 is an FDA 510(k) clearance for the CYBREX TM FPQ FLUORESCENE POLARIZATION. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 862.2560 - the FDA pathology 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 Laboratories devices

FDA 510(k) Submission Details - K802579

510(k) Number K802579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1980
Decision Date November 12, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 77d · This submission: 23d
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 29
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K802579.
A FLUOROMETER
K813540 · American Diagnostic Corp. · Dec 1981
SYVA ADVANCE TM FLUOROMETER
K813146 · Syva Co. · Nov 1981
LKB 4460 FLUORIMETER
K811019 · Lkb Instruments, Inc. · Apr 1981
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · Bio-Rad · Jul 1979
SPECTROPHOTOMETER MODEL 3000
K790235 · The Perkin-Elmer Corp. · Mar 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · The Perkin-Elmer Corp. · Mar 1979