Cleared Traditional

Elecsys CYFRA 21-1 CalCheck 5

K162173 · Roche Diagnostics · Immunology
Jan 2017
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K162173 is an FDA 510(k) clearance for the Elecsys CYFRA 21-1 CalCheck 5, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on January 12, 2017, 162 days after receiving the submission on August 3, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K162173 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2016
Decision Date January 12, 2017
Days to Decision 162 days
Submission Type Traditional
Review Panel Immunology (IM)
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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