Cleared Traditional

INCOS 50 MASS SPECTROMETER

K880418 · Finnigan Corp. · Toxicology
May 1988
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K880418 is an FDA 510(k) clearance for the INCOS 50 MASS SPECTROMETER, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Finnigan Corp. (Livingston, US). The FDA issued a Cleared decision on May 31, 1988, 120 days after receiving the submission on February 1, 1988. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2860.

Submission Details

510(k) Number K880418 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 1988
Decision Date May 31, 1988
Days to Decision 120 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