K152061 is an FDA 510(k) clearance for the IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 3, 2016, 223 days after receiving the submission on July 24, 2015.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K152061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2015 |
| Decision Date | March 03, 2016 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |