The following data is part of a premarket notification filed by Pb Diagnostic Systems, Inc. with the FDA for Opus(r) Rozo.
| Device ID | K911834 |
| 510k Number | K911834 |
| Device Name: | OPUS(R) ROZO |
| Classification | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii |
| Applicant | PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Contact | Kathleen Dray-lyons |
| Correspondent | Kathleen Dray-lyons PB DIAGNOSTIC SYSTEMS, INC. 151 UNIVERSITY AVE. Westwood, MA 02090 |
| Product Code | LGD |
| CFR Regulation Number | 866.3780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-25 |
| Decision Date | 1991-08-12 |