The following data is part of a premarket notification filed by Intl. Business Machines with the FDA for Automated 8400 Blood Cell Separator.
| Device ID | K831004 |
| 510k Number | K831004 |
| Device Name: | AUTOMATED 8400 BLOOD CELL SEPARATOR |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | INTL. BUSINESS MACHINES 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-29 |
| Decision Date | 1983-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35020583707000 | K831004 | 000 |
| 05020583707009 | K831004 | 000 |