Cleared Traditional

HANDI-WASH

K823787 · Dynatech Corp. · Chemistry
Mar 1983
Decision
83d
Days
Class 1
Risk

About This 510(k) Submission

K823787 is an FDA 510(k) clearance for the HANDI-WASH, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983, 83 days after receiving the submission on December 16, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K823787 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1982
Decision Date March 09, 1983
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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