Cleared Traditional

Atellica? CH Diazo Direct Bilirubin (D_DBil)

K223078 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jun 2023
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K223078 is an FDA 510(k) clearance for the Atellica? CH Diazo Direct Bilirubin (D_DBil), 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 June 12, 2023, 255 days after receiving the submission on September 30, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1110.

Submission Details

510(k) Number K223078 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2022
Decision Date June 12, 2023
Days to Decision 255 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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