The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Bone Alp.
| Device ID | K964764 |
| 510k Number | K964764 |
| Device Name: | OPUS BONE ALP |
| Classification | Electrophoretic Separation, Alkaline Phosphatase Isoenzymes |
| 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 | CIN |
| CFR Regulation Number | 862.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-01-24 |
| Summary: | summary |