Cleared Traditional

VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

K133550 · Maine Standards Company, LLC · Chemistry
Feb 2014
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K133550 is an FDA 510(k) clearance for the VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Maine Standards Company, LLC (Cumberland Foreside, US). The FDA issued a Cleared decision on February 5, 2014, 78 days after receiving the submission on November 19, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K133550 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2013
Decision Date February 05, 2014
Days to Decision 78 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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