Cleared Traditional

K780362 - SPECTROFLUOROMETER SF-330

K780362 is the FDA 510(k) clearance for SPECTROFLUOROMETER SF-330 by Varian Assoc., Inc.. It is a Class 1 Toxicology device (product code KHO) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K780362 · Varian Assoc., Inc. · Toxicology device
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Mar 1978
Decision
16d
Days
Class 1
Risk

K780362 is an FDA 510(k) clearance for the SPECTROFLUOROMETER SF-330. Classified as Fluorometer, For Clinical Use (product code KHO), Class I - General Controls.

Submitted by Varian Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 22, 1978 after a review of 16 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 Varian Assoc., Inc. devices

Submission Details

510(k) Number K780362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1978
Decision Date March 22, 1978
Days to Decision 16 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
71d faster than avg
Panel avg: 87d · This submission: 16d
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 25
Devices cleared under the same product code (KHO) and FDA review panel - the closest regulatory comparables to K780362.
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
HTSH RIA
K780122 · Abbott Laboratories · Feb 1978
DETECTOR, MODEL LC-100 FLUORESCENCE
K760261 · The Perkin-Elmer Corp. · Sep 1976