Cleared Traditional

MODEL 3030 ATOMIC ABSORPTION SPECTRO- (K820320) - FDA 510(k) Clearance

Class I Toxicology device.

K820320 · The Perkin-Elmer Corp. · Toxicology device
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Mar 1982
Decision
24d
Days
Class 1
Risk

K820320 is an FDA 510(k) clearance for the MODEL 3030 ATOMIC ABSORPTION SPECTRO-. Classified as Atomic Absorption Spectrophotometer, General Use (product code JXR), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on March 1, 1982 after a review of 24 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 The Perkin-Elmer Corp. devices

Submission Details

510(k) Number K820320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1982
Decision Date March 01, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 87d · This submission: 24d
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 K820320.
SPECTROPHOTOMETER, ATOMIC ABSORPTION
K780521 · Instrumentation Laboratory CO · May 1978
SPECTROPHOTOMETERS, ATOMIC ABSORPTION
K780522 · Instrumentation Laboratory CO · May 1978
SPECTROPHOTOMETEO IL MODEL 651
K771604 · Instrumentation Laboratory CO · Sep 1977
SPECTROPHOTOMETER, MODEL 751
K770645 · Instrumentation Laboratory CO · Jun 1977
SAMPLER, FLAMELESS (IL MODEL 555)
K760119 · Instrumentation Laboratory CO · Jul 1976