Cleared Traditional

Atellica? CH Creatinine_3 (Crea3)

K242685 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Dec 2024
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K242685 is an FDA 510(k) clearance for the Atellica? CH Creatinine_3 (Crea3), a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on December 4, 2024, 89 days after receiving the submission on September 6, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K242685 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2024
Decision Date December 04, 2024
Days to Decision 89 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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