The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus(r) Tobramycin.
| Device ID | K911940 |
| 510k Number | K911940 |
| Device Name: | OPUS(R) TOBRAMYCIN |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Lori Baranauskas |
| Correspondent | Lori Baranauskas PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-07-01 |