Cleared Traditional

MINI-SHAKER

K813318 · Dynatech Corp. · Chemistry
Dec 1981
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K813318 is an FDA 510(k) clearance for the MINI-SHAKER, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on December 17, 1981, 23 days after receiving the submission on November 24, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K813318 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1981
Decision Date December 17, 1981
Days to Decision 23 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