Cleared Traditional

K821219 - SERIES 4 LIQUID CHROMATOGRAPH

K821219 is an FDA 510(k) clearance for SERIES 4 LIQUID CHROMATOGRAPH, manufactured by The Perkin-Elmer Corp.. The device is a Class 1 Toxicology device with product code LDM cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K821219 · The Perkin-Elmer Corp. · Toxicology device
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May 1982
Decision
31d
Days
Class 1
Risk

K821219 is an FDA 510(k) clearance for the SERIES 4 LIQUID CHROMATOGRAPH. Classified as Instrumentation, High Pressure Liquid Chromatography (product code LDM), Class I - General Controls.

Submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1982 after a review of 31 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 - K821219

510(k) Number K821219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date May 28, 1982
Days to Decision 31 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
56d faster than avg
Panel avg: 87d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

LDM Device Classification - Class 1, General Controls

Product Code LDM Instrumentation, High Pressure Liquid Chromatography
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 - LDM Instrumentation, High Pressure Liquid Chromatography

All 17
Devices cleared under the same product code (LDM) and FDA review panel - the closest regulatory comparables to K821219.
REPORTING INTEGRATOR 3392A
K833113 · Hewlett-Packard Co. · Nov 1983
LIQUID CHROMATOGRAPH 1090 SERIES
K832375 · Hewlett-Packard Co. · Oct 1983
SERIES 10 LIQUID CHROMOTOGRAPH
K821727 · The Perkin-Elmer Corp. · Jun 1982
MODEL LC-85 UV DETECTOR
K810304 · The Perkin-Elmer Corp. · Feb 1981
3390A REPORTING INTEGRATOR
K802031 · Hewlett-Packard Co. · Sep 1980
PREP I AUTOMATED SAMPLE PROCESSOR
K780933 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1978