The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Innovance D-dimer And Innovance D-dimer Controls.
| Device ID | K081732 |
| 510k Number | K081732 |
| Device Name: | INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Contact | Kathleen A Dray-lyons |
| Correspondent | Kathleen A Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE M/S 514 Newark, DE 19702 |
| Product Code | DAP |
| CFR Regulation Number | 864.7320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-19 |
| Decision Date | 2008-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768027611 | K081732 | 000 |
| 00842768023668 | K081732 | 000 |
| 00630414640181 | K081732 | 000 |
| 00842768019265 | K081732 | 000 |