Cleared Traditional

ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD

K103615 · Alfa Wassermann Diagnostic Technologies, Inc. · Chemistry
Sep 2011
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K103615 is an FDA 510(k) clearance for the ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD, a Urease, Photometric, Urea Nitrogen (Class II — Special Controls, product code CDN), submitted by Alfa Wassermann Diagnostic Technologies, Inc. (West Caldwell, US). The FDA issued a Cleared decision on September 8, 2011, 273 days after receiving the submission on December 9, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1770.

Submission Details

510(k) Number K103615 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2010
Decision Date September 08, 2011
Days to Decision 273 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDN — Urease, Photometric, Urea Nitrogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1770

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