Cleared Traditional

ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347

K983503 · Boehringer Mannheim Corp. · Chemistry
Dec 1998
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K983503 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347, a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I — General Controls, product code CEO), submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 1, 1998, 56 days after receiving the submission on October 6, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K983503 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1998
Decision Date December 01, 1998
Days to Decision 56 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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