Cleared Traditional

ROCHE ACETAMINOPHEN ASSAY

K110726 · Roche Diagnostics · Chemistry
Dec 2011
Decision
282d
Days
Class 2
Risk

About This 510(k) Submission

K110726 is an FDA 510(k) clearance for the ROCHE ACETAMINOPHEN ASSAY, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on December 23, 2011, 282 days after receiving the submission on March 16, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K110726 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2011
Decision Date December 23, 2011
Days to Decision 282 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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