The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Protein Control Sy/l, M And H.
| Device ID | K955858 |
| 510k Number | K955858 |
| Device Name: | N/T PROTEIN CONTROL SY/L, M AND H |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-27 |
| Decision Date | 1996-02-21 |