Cleared Traditional

MIC-2000 PLUS, 96 CHANNEL DISPENSER

K820821 · Dynatech Corp. · Microbiology
Apr 1982
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K820821 is an FDA 510(k) clearance for the MIC-2000 PLUS, 96 CHANNEL DISPENSER, a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982, 21 days after receiving the submission on March 24, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number K820821 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1982
Decision Date April 14, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTC — Device, Microtiter Diluting/dispensing
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2500

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