Cleared Traditional

K813146 - SYVA ADVANCE TM FLUOROMETER

K813146 is the FDA 510(k) clearance for SYVA ADVANCE TM FLUOROMETER by Syva Co.. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K813146 · Syva Co. · Chemistry device
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Nov 1981
Decision
21d
Days
Class 1
Risk

K813146 is an FDA 510(k) clearance for the SYVA ADVANCE TM FLUOROMETER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981 after a review of 21 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 Syva Co. devices

Submission Details

510(k) Number K813146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1981
Decision Date November 27, 1981
Days to Decision 21 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
67d faster than avg
Panel avg: 88d · This submission: 21d
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 K813146.
CLINISTAT TDA SERIES
K823112 · Miles Laboratories, Inc. · Nov 1982
FLUOROSTAT FLUOROMETER
K822701 · Miles Laboratories, Inc. · Oct 1982
A FLUOROMETER
K813540 · American Diagnostic Corp. · Dec 1981
LKB 4460 FLUORIMETER
K811019 · Lkb Instruments, Inc. · Apr 1981
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · Abbott Laboratories · Nov 1980
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329 · Bio-Rad · Jul 1979