Cleared Traditional

VALIDATE Anemia Calibration Verification/ Linearity Test Kit

K142964 · Maine Standards Company, LLC · Chemistry
Apr 2015
Decision
198d
Days
Class 1
Risk

About This 510(k) Submission

K142964 is an FDA 510(k) clearance for the VALIDATE Anemia Calibration Verification/ Linearity Test Kit, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Maine Standards Company, LLC (Cumberland Foreside, US). The FDA issued a Cleared decision on April 30, 2015, 198 days after receiving the submission on October 14, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K142964 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 2014
Decision Date April 30, 2015
Days to Decision 198 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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