The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Dimension Exl High-sensitivity Troponin I (tnih) Assay.
| Device ID | K190675 |
| 510k Number | K190675 |
| Device Name: | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 |
| Contact | Laura J. Duggan |
| Correspondent | Laura J. Duggan Siemens Healthcare Diagnostics, Inc. 500 GBC Drive Newark, DE 19714 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768037726 | K190675 | 000 |