The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Software, Blood Virus Application.
| Device ID | BK130020 |
| 510k Number | BK130020 |
| Device Name: | SOFTWARE, BLOOD VIRUS APPLICATION |
| Classification | Software, Blood Virus Applications |
| Applicant | Abbott Laboratories dept 09va, Bldg Ap8-1 100 Abbott Park Road Abbott Park, IL 60064 |
| 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 | 2013-04-16 |
| Decision Date | 2013-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740138400 | BK130020 | 000 |