Device Classification Name |
separator, automated, blood cell, diagnostic
|
510(k) Number |
K760856 |
Device Name |
BLOOD CELL PROCESSOR MODEL 2 IBM 2991 |
Applicant |
INTL. BUSINESS MACHINES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INTL. BUSINESS MACHINES |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 864.9245
|
Classification Product Code |
|
Date Received | 10/15/1976 |
Decision Date | 01/10/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|