The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Modification Of Opus Ferritin Test System.
| Device ID | K973202 |
| 510k Number | K973202 |
| Device Name: | MODIFICATION OF OPUS FERRITIN TEST SYSTEM |
| Classification | Ferritin, Antigen, Antiserum, Control |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Ruth Forstadt |
| Correspondent | Ruth Forstadt BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | DBF |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-08 |
| Decision Date | 1997-09-12 |
| Summary: | summary |