Device Classification Name |
analyzer, chemistry (photometric, discrete), for clinical use
|
510(k) Number |
K803267 |
Device Name |
AUTOMATED IMMUOCHEMISTRY SYSTEM |
Applicant |
BECKMAN INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BECKMAN INSTRUMENTS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.2160
|
Classification Product Code |
|
Date Received | 12/29/1980 |
Decision Date | 01/16/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|