Cleared Traditional

ADVIA IMS VALPROIC ACID METHOD

K042807 · Bayer Healthcare, LLC · Chemistry
Feb 2005
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K042807 is an FDA 510(k) clearance for the ADVIA IMS VALPROIC ACID METHOD, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Bayer Healthcare, LLC (New York, US). The FDA issued a Cleared decision on February 8, 2005, 119 days after receiving the submission on October 12, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K042807 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 2004
Decision Date February 08, 2005
Days to Decision 119 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LEG — Enzyme Immunoassay, Valproic Acid
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3645

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