K222116 is an FDA 510(k) clearance for the Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP). This device is classified as a Radioimmunoassay, Thyroid-stimulating Hormone (Class II - Special Controls, product code JLW).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 13, 2023, 360 days after receiving the submission on July 18, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1690.
| 510(k) Number | K222116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 2022 |
| Decision Date | July 13, 2023 |
| Days to Decision | 360 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | JLW — Radioimmunoassay, Thyroid-stimulating Hormone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1690 |