The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Tdm Controls.
| Device ID | K954291 |
| 510k Number | K954291 |
| Device Name: | OPUS TDM CONTROLS |
| Classification | Drug Mixture Control Materials |
| 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 | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-14 |
| Decision Date | 1995-11-20 |
| Summary: | summary |