The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Stratus Cs Acute Care D-dimer.
| Device ID | K110303 |
| 510k Number | K110303 |
| Device Name: | STRATUS CS ACUTE CARE D-DIMER |
| Classification | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 514 Newark, DE 19702 |
| Contact | Kathleen Ann Dray-lyons |
| Correspondent | Kathleen Ann Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE MS 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 | 2011-02-01 |
| Decision Date | 2011-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414986166 | K110303 | 000 |