Cleared Traditional

K822701 - FLUOROSTAT FLUOROMETER

K822701 is the FDA 510(k) clearance for FLUOROSTAT FLUOROMETER by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K822701 · Miles Laboratories, Inc. · Chemistry device
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Oct 1982
Decision
31d
Days
Class 1
Risk

K822701 is an FDA 510(k) clearance for the FLUOROSTAT FLUOROMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 8, 1982 after a review of 31 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K822701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 08, 1982
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
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 K822701.
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984 · Lkb Instruments, Inc. · May 1985
CLINISTAT TDA SERIES
K823112 · Miles Laboratories, Inc. · Nov 1982
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