Cleared Traditional

CYBERFLUOR 615 IMMUNOANALYZER (K872803) - FDA 510(k) Clearance

Class I Chemistry device.

K872803 · Cyberfluor, Inc. · Chemistry device
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Sep 1987
Decision
49d
Days
Class 1
Risk

K872803 is an FDA 510(k) clearance for the CYBERFLUOR 615 IMMUNOANALYZER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Cyberfluor, Inc. (Ontario M5t 1x4, CA). The FDA issued a Cleared decision on September 2, 1987 after a review of 49 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 Cyberfluor, Inc. devices

Submission Details

510(k) Number K872803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1987
Decision Date September 02, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
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 37
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K872803.
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130 · Baxter Healthcare Corp · Sep 1991
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908 · Baxter Healthcare Corp · Mar 1989
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
SYVA ADVANCE TM FLUOROMETER
K813146 · Syva Co. · Nov 1981
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · Abbott Laboratories · Nov 1980
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · Bio-Rad · Jul 1979