Cleared Traditional

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT

K041643 · Beckman Coulter, Inc. · Chemistry
Aug 2004
Decision
62d
Days
Class 1
Risk

About This 510(k) Submission

K041643 is an FDA 510(k) clearance for the SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 18, 2004, 62 days after receiving the submission on June 17, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K041643 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2004
Decision Date August 18, 2004
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1580

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