The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Py.
| Device ID | K951012 |
| 510k Number | K951012 |
| Device Name: | N/T PROTEIN CONTROL PY |
| Classification | Plasma, Fibrinogen Control |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | GIL |
| Subsequent Product Code | DEM |
| Subsequent Product Code | GIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-03-06 |
| Decision Date | 1995-04-17 |