Cleared Traditional

ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35

K090358 · Abbott Laboratories, Inc. · Chemistry
Aug 2009
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K090358 is an FDA 510(k) clearance for the ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35, a Enzyme Immunoassay, Valproic Acid (Class II — Special Controls, product code LEG), submitted by Abbott Laboratories, Inc. (Abbott Park, US). The FDA issued a Cleared decision on August 6, 2009, 175 days after receiving the submission on February 12, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3645.

Submission Details

510(k) Number K090358 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2009
Decision Date August 06, 2009
Days to Decision 175 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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