Cleared Traditional

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET

K130157 · Aalto Scientific, Ltd. · Chemistry
Mar 2013
Decision
55d
Days
Class 1
Risk

About This 510(k) Submission

K130157 is an FDA 510(k) clearance for the AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on March 19, 2013, 55 days after receiving the submission on January 23, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K130157 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2013
Decision Date March 19, 2013
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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