The following data is part of a premarket notification filed by Life Technologies Corporation with the FDA for Qualitative Test For Hla, Non-diagnostic.
Device ID | BK110038 |
510k Number | BK110038 |
Device Name: | Qualitative Test For HLA, Non-diagnostic |
Classification | Test, Qualitative, For Hla, Non-diagnostic |
Applicant | Life Technologies Corporation 9099 North Deerbrook Trail Brown Deer, WI 53223 |
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 | 2011-08-02 |
Decision Date | 2013-02-05 |