Cleared Traditional

K823112 - CLINISTAT TDA SERIES

K823112 is the FDA 510(k) clearance for CLINISTAT TDA SERIES by Miles Laboratories, Inc.. It is a Class 1 Toxicology device (product code KHO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K823112 · Miles Laboratories, Inc. · Toxicology device
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Nov 1982
Decision
39d
Days
Class 1
Risk

K823112 is an FDA 510(k) clearance for the CLINISTAT TDA SERIES. 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 November 29, 1982 after a review of 39 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K823112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1982
Decision Date November 29, 1982
Days to Decision 39 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
48d faster than avg
Panel avg: 87d · This submission: 39d
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 K823112.
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
FLUOROSTAT FLUOROMETER
K822701 · Miles Laboratories, Inc. · Oct 1982
A FLUOROMETER
K813540 · American Diagnostic Corp. · Dec 1981
SYVA ADVANCE TM FLUOROMETER
K813146 · Syva Co. · Nov 1981