Cleared Traditional

MINIWASH II

K813640 · Dynatech Corp. · Chemistry
Jan 1982
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K813640 is an FDA 510(k) clearance for the MINIWASH II, 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 January 28, 1982, 28 days after receiving the submission on December 31, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K813640 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1981
Decision Date January 28, 1982
Days to Decision 28 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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