The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Innovance D-dimer, Model Opbp09.
| Device ID | K091916 |
| 510k Number | K091916 |
| Device Name: | INNOVANCE D-DIMER, MODEL OPBP09 |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Kathleen Ann Dray-lyons |
| Correspondent | Kathleen Ann Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-10-29 |
| Summary: | summary |