The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus T4 Controls.
| Device ID | K953097 |
| 510k Number | K953097 |
| Device Name: | OPUS T4 CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| 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 | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-03 |
| Decision Date | 1995-08-24 |