Device Classification Name |
Enzymatic Esterase--Oxidase, Cholesterol
|
510(k) Number |
K761089 |
Device Name |
GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT |
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 | 862.1175
|
Classification Product Code |
|
Date Received | 11/22/1976 |
Decision Date | 01/25/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|