Cleared Traditional

INORGANIC PHOSPHORUS REAGENT SET

K844182 · Livonia Diagnostics, Inc. · Chemistry
Nov 1984
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K844182 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS REAGENT SET, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Livonia Diagnostics, Inc. (Livonia, US). The FDA issued a Cleared decision on November 9, 1984, 14 days after receiving the submission on October 26, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K844182 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1984
Decision Date November 09, 1984
Days to Decision 14 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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