The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Software, Blood Virus Application.
Device ID | BK080015 |
510k Number | BK080015 |
Device Name: | SOFTWARE, BLOOD VIRUS APPLICATION |
Classification | Software, Blood Virus Applications |
Applicant | Abbott Laboratories 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 | 2008-03-28 |
Decision Date | 2008-04-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00380740138394 | BK080015 | 000 |