Cleared Traditional

ION TRAP DETECTOR

K880090 · Finnigan Corp. · Chemistry
Mar 1988
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K880090 is an FDA 510(k) clearance for the ION TRAP DETECTOR, a Mass Spectrometer, Clinical Use (Class I — General Controls, product code DOP), submitted by Finnigan Corp. (San Jose, US). The FDA issued a Cleared decision on March 15, 1988, 63 days after receiving the submission on January 12, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2860.

Submission Details

510(k) Number K880090 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1988
Decision Date March 15, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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

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