K191595 is an FDA 510(k) clearance for the ARCHITECT STAT High Sensitivity Troponin-I. This device is classified as a Immunoassay Method, Troponin Subunit (Class II - Special Controls, product code MMI).
Submitted by Abbott Laboratories Diagnostics Division (Abbott Park, US). The FDA issued a Cleared decision on September 13, 2019, 88 days after receiving the submission on June 17, 2019.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.
| 510(k) Number | K191595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2019 |
| Decision Date | September 13, 2019 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | MMI — Immunoassay Method, Troponin Subunit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1215 |