The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Automated Blood Cell Separator -filtration.
| Device ID | BK870022 |
| 510k Number | BK870022 |
| Device Name: | Automated Blood Cell Separator -Filtration |
| 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 | 1987-08-25 |
| Decision Date | 1988-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583701008 | BK870022 | 0 |
| 05020583700109 | BK870022 | 0 |
| 05020583700512 | BK870022 | 0 |
| 05020583700307 | BK870022 | 0 |
| 05020583700604 | BK870022 | 0 |
| 05020583701007 | BK870022 | 0 |
| 35020583700100 | BK870022 | 0 |
| 35020583700308 | BK870022 | 0 |
| 35020583700407 | BK870022 | 0 |
| 35020583700513 | BK870022 | 0 |
| 35020583700605 | BK870022 | 0 |
| 05020583700406 | BK870022 | 0 |