Cleared Traditional

AUDIT MICROCV RF/CRP LINEARITY SET

K101226 · Aalto Scientific, Ltd. · Immunology
Aug 2010
Decision
120d
Days
Class 1
Risk

About This 510(k) Submission

K101226 is an FDA 510(k) clearance for the AUDIT MICROCV RF/CRP LINEARITY SET, 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 August 31, 2010, 120 days after receiving the submission on May 3, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K101226 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2010
Decision Date August 31, 2010
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
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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