The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus Cmv Test System-modification.
| Device ID | K963084 |
| 510k Number | K963084 |
| Device Name: | OPUS CMV TEST SYSTEM-MODIFICATION |
| Classification | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Applicant | BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy Johansen |
| Correspondent | Nancy Johansen BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LFZ |
| CFR Regulation Number | 866.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-08 |
| Decision Date | 1996-10-09 |
| Summary: | summary |