Cleared Traditional

SMI MULTI-TUBE VORTEXER

K801145 · Scientific Manufacturing Industries · Chemistry
Jun 1980
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K801145 is an FDA 510(k) clearance for the SMI MULTI-TUBE VORTEXER, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by Scientific Manufacturing Industries (Walker, US). The FDA issued a Cleared decision on June 9, 1980, 27 days after receiving the submission on May 13, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K801145 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 1980
Decision Date June 09, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JRQ — Shaker/stirrer
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2050