The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Troponin I.
| Device ID | K955284 |
| 510k Number | K955284 |
| Device Name: | OPUS TROPONIN I |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Philip Fantasia |
| Correspondent | Philip Fantasia BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-16 |
| Decision Date | 1996-01-25 |