The following data is part of a premarket notification filed by Fujirebio America Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
Device ID | BK960092 |
510k Number | BK960092 |
Device Name: | Automated Blood Grouping And Antibody Test Systems |
Classification | System, Test, Automated Blood Grouping And Antibody |
Applicant | Fujirebio America Inc. 30 Two Bridges Road suite 250 Fairfield, NJ 07004 US |
Product Code | KSZ |
CFR Regulation Number | 864.9175 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-12-11 |
Decision Date | 1998-10-28 |