Cleared Traditional

K810536 - ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB

K810536 is an FDA 510(k) clearance for ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Toxicology device with product code JXR cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K810536 · The Perkin-Elmer Corp. · Toxicology device
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Mar 1981
Decision
19d
Days
Class 1
Risk

K810536 is an FDA 510(k) clearance for the ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB. 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 17, 1981 after a review of 19 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

FDA 510(k) Submission Details - K810536

510(k) Number K810536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1981
Decision Date March 17, 1981
Days to Decision 19 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
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

JXR Device Classification - Class 1, General Controls

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 K810536.
ICP/6500 INDUCTIVELY-COUPLED PLASMA-
K842496 · The Perkin-Elmer Corp. · Aug 1984
INDUCTIVELY-COUPLED PLASMA SPECTROMETER
K830799 · The Perkin-Elmer Corp. · Apr 1983
MODEL 3030 ATOMIC ABSORPTION SPECTRO-
K820320 · The Perkin-Elmer Corp. · Mar 1982
SPECTROPHATOMETER MODELS 2280 & 2380AA
K792557 · The Perkin-Elmer Corp. · Jan 1980
ATOMIC SPECTROSCOPY SYSTEM
K792146 · The Perkin-Elmer Corp. · Nov 1979
MODEL MHS-20, ATOMIC ABSORPTION ACCESS
K791074 · The Perkin-Elmer Corp. · Aug 1979