Cleared Traditional

ELECSYS CA 19-9 CALCHECK 5

K101365 · Roche Diagnostics Corp. · Immunology
Oct 2010
Decision
141d
Days
Class 1
Risk

About This 510(k) Submission

K101365 is an FDA 510(k) clearance for the ELECSYS CA 19-9 CALCHECK 5, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 5, 2010, 141 days after receiving the submission on May 17, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K101365 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2010
Decision Date October 05, 2010
Days to Decision 141 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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