Cleared Traditional

STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER

K042169 · Stanbio Laboratory · Chemistry
Mar 2005
Decision
215d
Days
Class 1
Risk

About This 510(k) Submission

K042169 is an FDA 510(k) clearance for the STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER, a Analyzer, Chemistry (photometric, Discrete), For Clinical Use (Class I — General Controls, product code JJE), submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on March 14, 2005, 215 days after receiving the submission on August 11, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2160.

Submission Details

510(k) Number K042169 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2004
Decision Date March 14, 2005
Days to Decision 215 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJE — Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2160

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