Device Classification Name |
Colorimeter, Photometer, Spectrophotometer For Clinical Use
|
510(k) Number |
K760232 |
Device Name |
PRINTER, IL 460 |
Applicant |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
INSTRUMENTATION LABORATORY CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 862.2300 |
Classification Product Code |
|
Date Received | 07/14/1976 |
Decision Date | 08/26/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|