Cleared Traditional

RFA-300 RAPID FLOW ANALYZER W/COMPUTER

K883020 · Alpkem Corp. · Chemistry
Sep 1988
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K883020 is an FDA 510(k) clearance for the RFA-300 RAPID FLOW ANALYZER W/COMPUTER, a Analyzer, Chemistry, Micro, For Clinical Use (Class I — General Controls, product code JJF), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on September 2, 1988, 45 days after receiving the submission on July 19, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2170.

Submission Details

510(k) Number K883020 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1988
Decision Date September 02, 1988
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJF — Analyzer, Chemistry, Micro, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2170

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