Cleared Traditional

K813540 - A FLUOROMETER

K813540 is the FDA 510(k) clearance for A FLUOROMETER by American Diagnostic Corp.. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K813540 · American Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
10d
Days
Class 1
Risk

K813540 is an FDA 510(k) clearance for the A FLUOROMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by American Diagnostic Corp. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 10 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 American Diagnostic Corp. devices

Submission Details

510(k) Number K813540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1981
Decision Date December 31, 1981
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 88d · This submission: 10d
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 11
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K813540.
HEMAFLUOR REAGENT KIT
K860309 · Helena Laboratories · Jul 1986
CLINISTAT TDA SERIES
K823112 · Miles Laboratories, Inc. · Nov 1982
FLUOROSTAT FLUOROMETER
K822701 · Miles Laboratories, Inc. · Oct 1982
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