Cleared Traditional

SELECTA 20/60 CHEMISTRY ANALYZER

K942922 · Select Medical Systems, Inc. · Chemistry
Jul 1995
Decision
393d
Days
Class 1
Risk

About This 510(k) Submission

K942922 is an FDA 510(k) clearance for the SELECTA 20/60 CHEMISTRY ANALYZER, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Select Medical Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on July 19, 1995, 393 days after receiving the submission on June 21, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K942922 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 1994
Decision Date July 19, 1995
Days to Decision 393 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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