Cleared Traditional

ULTRAWASH II

K863624 · Dynatech Laboratories, Inc. · Chemistry
Oct 1986
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K863624 is an FDA 510(k) clearance for the ULTRAWASH II, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on October 21, 1986, 35 days after receiving the submission on September 16, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K863624 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 1986
Decision Date October 21, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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