The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Uy.
| Device ID | K914890 |
| 510k Number | K914890 |
| Device Name: | N/T PROTEIN CONTROL UY |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 17 CHUBB WAY Somerville, NJ 08876 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-31 |
| Decision Date | 1992-02-06 |