Cleared Abbreviated

ADVIA IMS CPSA CONTROL

K061137 · Bayer Healthcare, LLC · Immunology
Jul 2006
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K061137 is an FDA 510(k) clearance for the ADVIA IMS CPSA CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on July 6, 2006, 73 days after receiving the submission on April 24, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K061137 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 2006
Decision Date July 06, 2006
Days to Decision 73 days
Submission Type Abbreviated
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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