Cleared Traditional

K843568 - LIQUID CHROMATOGRAPH 400

K843568 is an FDA 510(k) clearance for LIQUID CHROMATOGRAPH 400, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Toxicology device with product code KZR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K843568 · The Perkin-Elmer Corp. · Toxicology device
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Nov 1984
Decision
71d
Days
Class 1
Risk

K843568 is an FDA 510(k) clearance for the LIQUID CHROMATOGRAPH 400. Classified as Chromatography (liquid, Gel), Clinical Use (product code KZR), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Norwalk, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.2260 - 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 - K843568

510(k) Number K843568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date November 20, 1984
Days to Decision 71 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
16d faster than avg
Panel avg: 87d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

KZR Device Classification - Class 1, General Controls

Product Code KZR Chromatography (liquid, Gel), Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2260
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 - KZR Chromatography (liquid, Gel), Clinical Use

All 10
Devices cleared under the same product code (KZR) and FDA review panel - the closest regulatory comparables to K843568.
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