K222104 is an FDA 510(k) clearance for the Atellica® CH Diazo Total Bilirubin (D_TBil). This device is classified as 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 FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K222104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | CIG — Diazo Colorimetry, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |