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 |