Cleared Traditional

SMI MULTIPETTOR(TM)

K863887 · American Dade · Chemistry
Nov 1986
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K863887 is an FDA 510(k) clearance for the SMI MULTIPETTOR(TM), a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on November 5, 1986, 30 days after receiving the submission on October 6, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K863887 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1986
Decision Date November 05, 1986
Days to Decision 30 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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