Cleared Traditional

PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416

K945322 · Emd Chemicals, Inc. · Chemistry
Dec 1994
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K945322 is an FDA 510(k) clearance for the PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 7, 1994, 36 days after receiving the submission on November 1, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K945322 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1994
Decision Date December 07, 1994
Days to Decision 36 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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