Cleared Traditional

K770994 - FURNACE AUTOSAMPLER, MODEL 155 (FDA 510(k) Clearance)

Aug 1977
Decision
82d
Days
Class 1
Risk

K770994 is an FDA 510(k) clearance for the FURNACE AUTOSAMPLER, MODEL 155. This device is classified as a Mass Spectrometer, Clinical Use (Class I - General Controls, product code DOP).

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977, 82 days after receiving the submission on June 1, 1977.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.2860.

Submission Details

510(k) Number K770994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1977
Decision Date August 22, 1977
Days to Decision 82 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