The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus D-dimer.
| Device ID | K972316 |
| 510k Number | K972316 |
| Device Name: | OPUS D-DIMER |
| Classification | Fibrin Split Products |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | GHH |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-20 |
| Decision Date | 1997-09-09 |
| Summary: | summary |