The following data is part of a premarket notification filed by I. B. G. Systems Inc. with the FDA for Automated Cell-washing Centrifuge For Immune-hematology.
Device ID | BK920019 |
510k Number | BK920019 |
Device Name: | Automated Cell-washing Centrifuge For Immune-hematology |
Classification | Centrifuge, Cell-washing, Automated For Immuno-hematology |
Applicant | I. B. G. Systems Inc. p.o. Box 5306 Laytonsville, MD 20882 |
Product Code | KSN |
CFR Regulation Number | 864.9285 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-29 |
Decision Date | 1993-03-26 |