Cleared Traditional

WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311

K013095 · Wiener Laboratories Saic · Chemistry
Nov 2001
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K013095 is an FDA 510(k) clearance for the WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Wiener Laboratories Saic (Rosario, Santa Fe, AR). The FDA issued a Cleared decision on November 16, 2001, 60 days after receiving the submission on September 17, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K013095 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2001
Decision Date November 16, 2001
Days to Decision 60 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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