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 |