Cleared Traditional

ION TRAP DETECTOR (ITD)

K872464 · The Perkin-Elmer Corp. · Toxicology
Aug 1987
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K872464 is an FDA 510(k) clearance for the ION TRAP DETECTOR (ITD), a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by The Perkin-Elmer Corp.. The FDA issued a Cleared decision on August 11, 1987, 49 days after receiving the submission on June 23, 1987. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2860.

Submission Details

510(k) Number K872464 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1987
Decision Date August 11, 1987
Days to Decision 49 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DOP — Mass Spectrometer, Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2860