Cleared Traditional

Atellica CH Enzymatic Creatinine_3 (ECre3)

K212223 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Nov 2021
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K212223 is an FDA 510(k) clearance for the Atellica CH Enzymatic Creatinine_3 (ECre3), a Enzymatic Method, Creatinine (Class II — Special Controls, product code JFY), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on November 24, 2021, 131 days after receiving the submission on July 16, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K212223 FDA.gov
FDA Decision Cleared SESE
Date Received July 16, 2021
Decision Date November 24, 2021
Days to Decision 131 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JFY — Enzymatic Method, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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