Cleared Traditional

Atellica? CH Diazo Total Bilirubin (D_TBil)

K222104 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Mar 2023
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K222104 is an FDA 510(k) clearance for the Atellica? CH Diazo Total Bilirubin (D_TBil), a Diazo Colorimetry, Bilirubin (Class II — Special Controls, product code CIG), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on March 20, 2023, 245 days after receiving the submission on July 18, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K222104 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date March 20, 2023
Days to Decision 245 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CIG — Diazo Colorimetry, Bilirubin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1110

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