Cleared Traditional

RFA/2 RAPID FLOW ANALYZER W/COMPUTER

K890332 · Alpkem Corp. · Chemistry

Feb 1989

Decision

25d

Days

Class 1

Risk

About This 510(k) Submission

K890332 is an FDA 510(k) clearance for the RFA/2 RAPID FLOW ANALYZER W/COMPUTER, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on February 17, 1989, 25 days after receiving the submission on January 23, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K890332 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 23, 1989
Decision Date	February 17, 1989
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JJC — Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.2150