Cleared Traditional

Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)

K161494 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Nov 2016
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K161494 is an FDA 510(k) clearance for the Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL), a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on November 15, 2016, 167 days after receiving the submission on June 1, 2016. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K161494 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2016
Decision Date November 15, 2016
Days to Decision 167 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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