Cleared Traditional

SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT

K971363 · Carolina Liquid Chemistries Corp. · Chemistry
Apr 1997
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K971363 is an FDA 510(k) clearance for the SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on April 21, 1997, 14 days after receiving the submission on April 7, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K971363 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1997
Decision Date April 21, 1997
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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