Cleared Traditional

PHOSPHORUS

K895999 · American Monitor Corp. · Chemistry
Jan 1990
Decision
90d
Days
Class 1
Risk

About This 510(k) Submission

K895999 is an FDA 510(k) clearance for the PHOSPHORUS, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by American Monitor Corp. (Indianapolis, US). The FDA issued a Cleared decision on January 11, 1990, 90 days after receiving the submission on October 13, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K895999 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 1989
Decision Date January 11, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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