The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Atellica Im High-sensitivity Troponin I (tnih).
| Device ID | K171566 |
| 510k Number | K171566 |
| Device Name: | Atellica IM High-Sensitivity Troponin I (TNIH) |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Matthew Gee |
| Correspondent | Matthew Gee Siemens Healthcare Diagnostics Inc. 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2018-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414006758 | K171566 | 000 |
| 00630414006703 | K171566 | 000 |
| 00630414293783 | K171566 | 000 |