Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K851100 |
Device Name |
CHEM PRO 1000 CHEMISTRY ANALYSIS |
Applicant |
SEN TECH MEDICAL CORP. |
3771 LEXINGTON AVE. |
ARDEN HILLS,
MN
55112
|
|
Applicant Contact |
WALTER L SEMBROWICH |
Correspondent |
SEN TECH MEDICAL CORP. |
3771 LEXINGTON AVE. |
ARDEN HILLS,
MN
55112
|
|
Correspondent Contact |
WALTER L SEMBROWICH |
Regulation Number | 862.1600
|
Classification Product Code |
|
Date Received | 03/19/1985 |
Decision Date | 07/09/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|