Cleared Traditional

SERIES 410 LC PUMP

K860197 · The Perkin-Elmer Corp. · Toxicology
Mar 1986
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K860197 is an FDA 510(k) clearance for the SERIES 410 LC PUMP, a Chromatography (liquid, Gel), Clinical Use (Class I — General Controls, product code KZR), submitted by The Perkin-Elmer Corp.. The FDA issued a Cleared decision on March 17, 1986, 54 days after receiving the submission on January 22, 1986. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2260.

Submission Details

510(k) Number K860197 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1986
Decision Date March 17, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

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

Similar Devices — KZR Chromatography (liquid, Gel), Clinical Use

All 14
2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
K973074 · Waters Corporation · Oct 1997
USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
K931227 · U.S. Drug Testing, Inc. · May 1993
COLUMNS LIQUID CHROMATOGRAPHY DPM
K905538 · Millpore Corp. · Jan 1991
SYVA SOLID PHASE COLUMNS SYSTEM II
K861392 · Syva Co. · Jun 1986
VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM
K851945 · Varian Assoc., Inc. · May 1985
LIQUID CHROMATOGRAPH 400
K843568 · The Perkin-Elmer Corp. · Nov 1984