The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Axsym Troponin-i Adv.
| Device ID | K060875 |
| 510k Number | K060875 |
| Device Name: | ABBOTT AXSYM TROPONIN-I ADV |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Contact | Margaret Prochniak |
| Correspondent | Margaret Prochniak ABBOTT LABORATORIES 100 ABBOTT PARK ROAD Abbott Park, IL 60064 -3500 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-30 |
| Decision Date | 2006-06-14 |
| Summary: | summary |