Cleared Traditional

SMI DIGITRON

K870406 · American Dade · Chemistry
Feb 1987
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K870406 is an FDA 510(k) clearance for the SMI DIGITRON, 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 February 25, 1987, 22 days after receiving the submission on February 3, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K870406 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1987
Decision Date February 25, 1987
Days to Decision 22 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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