Cleared Traditional

HEMOCUE ALBUMIN 201 ANALYZING SYSTEM

K053253 · Hemocue AB · Chemistry
Feb 2006
Decision
88d
Days
Class 1
Risk

About This 510(k) Submission

K053253 is an FDA 510(k) clearance for the HEMOCUE ALBUMIN 201 ANALYZING SYSTEM, a Automated Urinalysis System (Class I — General Controls, product code KQO), submitted by Hemocue AB (Lake Forest, US). The FDA issued a Cleared decision on February 17, 2006, 88 days after receiving the submission on November 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2900.

Submission Details

510(k) Number K053253 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2005
Decision Date February 17, 2006
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code KQO — Automated Urinalysis System
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2900

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