Device Classification Name |
separator, automated, blood cell, diagnostic
|
510(k) Number |
DK760856 |
Tradename |
IBM 2991 Blood Cell Processor, Model 2
|
Device Name |
Automated Blood Cell Separator -Filtration |
Original Applicant |
International Business Machines |
princeton,
NJ
08540
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 10/15/1976 |
Decision Date | 01/10/1977 |
Decision |
substantially equivalent (SE) |
Classification Advisory Committee |
Hematology
|
Review Advisory Committee |
Hematology
|
Type |
510(k) Traditional
|
Total Product Life Cycle (TPLC) |
TPLC Device Report
|
Reviewed by Third Party |
No
|
Expedited Review |
No
|
Combination Product |
No
|
In Vitro Product |
No
|
|
|