Cleared Traditional

ELECSYS INSULIN CALCHECK 5

K101075 · Roche Diagnostics Corp. · Chemistry
Jun 2010
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K101075 is an FDA 510(k) clearance for the ELECSYS INSULIN 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 June 11, 2010, 53 days after receiving the submission on April 19, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K101075 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 2010
Decision Date June 11, 2010
Days to Decision 53 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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