Cleared Traditional

ELECYS ANTI-CCP CALCHECK

K091601 · Roche Diagnostics Corp. · Chemistry
Sep 2009
Decision
114d
Days
Class 1
Risk

About This 510(k) Submission

K091601 is an FDA 510(k) clearance for the ELECYS ANTI-CCP CALCHECK, 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 September 25, 2009, 114 days after receiving the submission on June 3, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K091601 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2009
Decision Date September 25, 2009
Days to Decision 114 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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