Cleared Traditional

S/P VORTEX MIXER

K813148 · American Dade · Chemistry
Nov 1981
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K813148 is an FDA 510(k) clearance for the S/P VORTEX MIXER, a Shaker/stirrer (Class I — General Controls, product code JRQ), submitted by American Dade (Mchenry, US). The FDA issued a Cleared decision on November 24, 1981, 18 days after receiving the submission on November 6, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K813148 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 1981
Decision Date November 24, 1981
Days to Decision 18 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