The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Automated Blood Cell Separators.
Device ID | BK940016 |
510k Number | BK940016 |
Device Name: | Automated Blood Cell Separators |
Classification | Separator, Automated, Blood Cell, Diagnostic |
Applicant | Cobe Laboratories, Inc. 1185 Oak Street Lakewood, CO 80215 |
Product Code | GKT |
CFR Regulation Number | 864.9245 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-03-29 |
Decision Date | 1994-09-20 |