Cleared Traditional

AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5

K082714 · Aalto Scientific, Ltd. · Chemistry
Nov 2008
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K082714 is an FDA 510(k) clearance for the AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Aalto Scientific, Ltd. (Carlsbad, US). The FDA issued a Cleared decision on November 19, 2008, 63 days after receiving the submission on September 17, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K082714 FDA.gov
FDA Decision Cleared SESE
Date Received September 17, 2008
Decision Date November 19, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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