The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Hstnl.
| Device ID | K172787 |
| 510k Number | K172787 |
| Device Name: | Access HsTnl |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, MN 55318 |
| Contact | Jennifer Lee Bennett |
| Correspondent | Jennifer Bennett Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, MN 55318 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-15 |
| Decision Date | 2018-06-14 |
| Summary: | summary |