Cleared Traditional

AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5

K100715 · Aalto Scientific, Ltd. · Chemistry
Dec 2010
Decision
286d
Days
Class 1
Risk

About This 510(k) Submission

K100715 is an FDA 510(k) clearance for the AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5, 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 December 23, 2010, 286 days after receiving the submission on March 12, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K100715 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 2010
Decision Date December 23, 2010
Days to Decision 286 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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