Cleared Traditional

K901410 - TECHNICON RA-2000(TM) SYSTEM
(FDA 510(k) Clearance)

K901410 · Technicon Instruments Corp. · Chemistry

Jul 1990

Decision

113d

Days

Class 1

Risk

K901410 is an FDA 510(k) clearance for the TECHNICON RA-2000(TM) SYSTEM, a Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use (Class I — General Controls, product code JJC), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on July 17, 1990, 113 days after receiving the submission on March 26, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2150.

Submission Details

510(k) Number	K901410 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 1990
Decision Date	July 17, 1990
Days to Decision	113 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