Cleared Traditional

ELECSYS TROPONIN T CALCHECK 5

K092848 · Roche Diagnostics Corp. · Chemistry
Mar 2010
Decision
184d
Days
Class 1
Risk

About This 510(k) Submission

K092848 is an FDA 510(k) clearance for the ELECSYS TROPONIN T 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 March 19, 2010, 184 days after receiving the submission on September 16, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K092848 FDA.gov
FDA Decision Cleared SESE
Date Received September 16, 2009
Decision Date March 19, 2010
Days to Decision 184 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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