K170065 is an FDA 510(k) clearance for the ADVIA® Chemistry Total Bilirubin_2 (TBIL_2). This device is classified as a Enzymatic Method, Bilirubin (Class II - Special Controls, product code JFM).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 9, 2017, 59 days after receiving the submission on January 9, 2017.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1110.
| 510(k) Number | K170065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 2017 |
| Decision Date | March 09, 2017 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JFM — Enzymatic Method, Bilirubin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1110 |