The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Immulite 2000 Tsi Assay, Immulite 2000 Tsi Calibration Verification Material.
| Device ID | K152061 |
| 510k Number | K152061 |
| Device Name: | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Contact | Susan Brocchi |
| Correspondent | Susan Brocchi SIEMENS HEALTHCARE DIAGNOSTICS, INC. 511 BENEDICT AVENUE Tarrytown, NY 10591 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-24 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414597188 | K152061 | 000 |
| 00630414006680 | K152061 | 000 |