Cleared Special

MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO)

K014034 · Beckman Coulter, Inc. · Chemistry
Dec 2001
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K014034 is an FDA 510(k) clearance for the MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO), a Ph Rate Measurement, Carbon-dioxide (Class II — Special Controls, product code JFL), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on December 18, 2001, 11 days after receiving the submission on December 7, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number K014034 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2001
Decision Date December 18, 2001
Days to Decision 11 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFL — Ph Rate Measurement, Carbon-dioxide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1160

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