The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus(r) Vancomycin.
| Device ID | K924957 |
| 510k Number | K924957 |
| Device Name: | OPUS(R) VANCOMYCIN |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Nancy M Johansen |
| Correspondent | Nancy M Johansen PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1992-12-11 |