The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Myoglobin Controls.
| Device ID | K962841 |
| 510k Number | K962841 |
| Device Name: | OPUS MYOGLOBIN CONTROLS |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Ruth C Forstadt |
| Correspondent | Ruth C Forstadt 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 | 1996-07-22 |
| Decision Date | 1996-08-15 |
| Summary: | summary |