The following data is part of a premarket notification filed by Abbott Laboratories Diagnostics Division with the FDA for Architect Stat High Sensitivity Troponin-i.
| Device ID | K191595 |
| 510k Number | K191595 |
| Device Name: | ARCHITECT STAT High Sensitivity Troponin-I |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Abbott Laboratories Diagnostics Division Dept. 09AA, Bldg. AP8, 100 Abbott Park Road Abbott Park, IL 60064 -6038 |
| Contact | Judi Wallach |
| Correspondent | Judi Wallach Abbott Laboratories Diagnostics Division Dept. 09AA, Bldg, AP8, 100 Abbott Park Road Abbott Park, IL 60064 -6038 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-09-13 |
| Summary: | summary |