The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus Digitoxin.
| Device ID | K935229 |
| 510k Number | K935229 |
| Device Name: | OPUS DIGITOXIN |
| Classification | Radioimmunoassay, Digitoxin (125-i), Rabbit Antibody, Coated Tube Sep. |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy Johansen |
| Correspondent | Nancy Johansen PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | DPG |
| CFR Regulation Number | 862.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1993-12-22 |