Cleared Traditional

K791329 - FLUOROMATIC ANALYZER AND AUTOSAMPLER

K791329 is the FDA 510(k) clearance for FLUOROMATIC ANALYZER AND AUTOSAMPLER by Bio-Rad. It is a Class 1 Chemistry device (product code KHO) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K791329 · Bio-Rad · Chemistry device
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Jul 1979
Decision
12d
Days
Class 1
Risk

K791329 is an FDA 510(k) clearance for the FLUOROMATIC ANALYZER AND AUTOSAMPLER. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 12 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 Bio-Rad devices

Submission Details

510(k) Number K791329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1979
Decision Date July 30, 1979
Days to Decision 12 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
76d faster than avg
Panel avg: 88d · This submission: 12d
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 K791329.
SYVA ADVANCE TM FLUOROMETER
K813146 · Syva Co. · Nov 1981
LKB 4460 FLUORIMETER
K811019 · Lkb Instruments, Inc. · Apr 1981
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579 · Abbott Laboratories · Nov 1980
SPECTROPHOTOMETER MODEL 3000
K790235 · The Perkin-Elmer Corp. · Mar 1979
SPECTROPHOTOMETER MODEL 650-40
K790236 · The Perkin-Elmer Corp. · Mar 1979
SPECTROPHOTOMETER, FLUORESCENCE M.650-10
K780242 · The Perkin-Elmer Corp. · Mar 1978