Cleared Traditional

FIAX 420 DILUTOR

K843621 · Intl. Diagnostic Technology · Chemistry
Sep 1984
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K843621 is an FDA 510(k) clearance for the FIAX 420 DILUTOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on September 28, 1984, 14 days after receiving the submission on September 14, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K843621 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1984
Decision Date September 28, 1984
Days to Decision 14 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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