The following data is part of a premarket notification filed by Genetic Systems Corporation with the FDA for Software, Blood Virus Application.
Device ID | BK900011 |
510k Number | BK900011 |
Device Name: | SOFTWARE, BLOOD VIRUS APPLICATION |
Classification | Software, Blood Virus Applications |
Applicant | Genetic Systems Corporation 3005 First Avenue Seattle, WA 98121 |
Product Code | MTQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-08 |
Decision Date | 1991-03-15 |