The following data is part of a premarket notification filed by I. B. G. Systems Inc. with the FDA for Automated Blood Grouping And Antibody Test Systems.
Device ID | BK900015 |
510k Number | BK900015 |
Device Name: | Automated Blood Grouping And Antibody Test Systems |
Classification | System, Test, Automated Blood Grouping And Antibody |
Applicant | I. B. G. Systems Inc. p.o. Box 5306 Laytonsville, MD 20882 |
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 | 1990-04-02 |
Decision Date | 1990-09-20 |