Cleared Traditional

K780390 - SPECTROPHOTOMETER

K780390 is the FDA 510(k) clearance for SPECTROPHOTOMETER by Varian Assoc., Inc.. It is a Class 1 Toxicology device (product code JXR) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K780390 · Varian Assoc., Inc. · Toxicology device
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Mar 1978
Decision
12d
Days
Class 1
Risk

K780390 is an FDA 510(k) clearance for the SPECTROPHOTOMETER, ABSORPTION, ATOMIC. Classified as Atomic Absorption Spectrophotometer, General Use (product code JXR), 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 12 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2850 - 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 K780390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1978
Decision Date March 22, 1978
Days to Decision 12 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
75d faster than avg
Panel avg: 87d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXR Atomic Absorption Spectrophotometer, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2850
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 - JXR Atomic Absorption Spectrophotometer, General Use

All 28
Devices cleared under the same product code (JXR) and FDA review panel - the closest regulatory comparables to K780390.
SPECTROPHOTOMETERS, ATOMIC ABSORPTION
K780522 · Instrumentation Laboratory CO · May 1978
SPECTROPHOTOMETERS
K780342 · The Perkin-Elmer Corp. · Apr 1978
ATOMIZER, FURNACE, GRAPHITE
K780129 · The Perkin-Elmer Corp. · Apr 1978
SPECTROPHOTOMETER, MODEL 5000
K780112 · The Perkin-Elmer Corp. · Jan 1978
SPECTROPHOTOMETER - SERIES AA-575
K772165 · Varian Assoc., Inc. · Nov 1977
SPECTROPHOTOMETEO IL MODEL 651
K771604 · Instrumentation Laboratory CO · Sep 1977