The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Software, Blood Virus Application.
| Device ID | BK120013 |
| 510k Number | BK120013 |
| Device Name: | SOFTWARE, BLOOD VIRUS APPLICATION |
| Classification | Software, Blood Virus Applications |
| Applicant | Siemens Healthcare Diagnostics, Inc. p.o. Box 2466 Berkeley, CA 94702 |
| Product Code | MTQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-03-27 |