The following data is part of a premarket notification filed by Genetic Systems Corporation with the FDA for Qualitative Test For Hla, Non-diagnostic.
Device ID | BK870006 |
510k Number | BK870006 |
Device Name: | Qualitative Test For HLA, Non-diagnostic |
Classification | Test, Qualitative, For Hla, Non-diagnostic |
Applicant | Genetic Systems Corporation 3005 First Avenue Seattle, WA 98121 |
Product Code | MZI |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-01 |
Decision Date | 1987-07-20 |