Cleared Traditional

K843419 - EMIT 700 CANNABINOID CONTROL SET (FDA 510(k) Clearance)

Oct 1984
Decision
35d
Days
Class 1
Risk

K843419 is an FDA 510(k) clearance for the EMIT 700 CANNABINOID CONTROL SET. This device is classified as a Drug Specific Control Materials (Class I - General Controls, product code LAS).

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on October 5, 1984, 35 days after receiving the submission on August 31, 1984.

This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K843419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date October 05, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code LAS — Drug Specific Control Materials
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.3280