Device Classification Name |
electrode, ion specific, urea nitrogen
|
510(k) Number |
K855091 |
Device Name |
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS |
Applicant |
SENTECH MEDICAL CORP. |
3771 LEXINGTON AVE. |
ARDEN HILLS,
MN
55126
|
|
Applicant Contact |
WALTER L SEMBROWICH |
Correspondent |
SENTECH MEDICAL CORP. |
3771 LEXINGTON AVE. |
ARDEN HILLS,
MN
55126
|
|
Correspondent Contact |
WALTER L SEMBROWICH |
Regulation Number | 862.1770
|
Classification Product Code |
|
Date Received | 12/20/1985 |
Decision Date | 03/14/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|