Cleared Traditional

DCL MICROALBUMIN ASSAY, MODEL 252-20

K051191 · Diagnostic Chemicals , Ltd. · Chemistry
Jul 2005
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K051191 is an FDA 510(k) clearance for the DCL MICROALBUMIN ASSAY, MODEL 252-20, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on July 5, 2005, 56 days after receiving the submission on May 10, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K051191 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2005
Decision Date July 05, 2005
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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