The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus B12.
| Device ID | K953455 |
| 510k Number | K953455 |
| Device Name: | OPUS B12 |
| Classification | Radioassay, Vitamin B12 |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Sheila Keady |
| Correspondent | Sheila Keady BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | CDD |
| CFR Regulation Number | 862.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-19 |
| Decision Date | 1995-08-23 |