Cleared Traditional

NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL

K053553 · Polymedco, Inc. · Chemistry
Mar 2006
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K053553 is an FDA 510(k) clearance for the NYCOCARD U-ALBUMIN AND U-ALBUMIN CONTROL, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on March 9, 2006, 79 days after receiving the submission on December 20, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K053553 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2005
Decision Date March 09, 2006
Days to Decision 79 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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