K161954 is an FDA 510(k) clearance for the Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc). This device is classified as a Electrode, Ion Specific, Sodium (Class II - Special Controls, product code JGS).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on March 9, 2017, 234 days after receiving the submission on July 18, 2016.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K161954 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2016 |
| Decision Date | March 09, 2017 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JGS — Electrode, Ion Specific, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |