Device Classification Name |
Electrode, Ion Specific, Potassium
|
510(k) Number |
K840961 |
Device Name |
ESCHWEILER COMBI-ANALYSER MTA-500 |
Applicant |
U.S. SCIENCE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
U.S. SCIENCE, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 862.1600 |
Classification Product Code |
|
Date Received | 03/06/1984 |
Decision Date | 08/10/1984 |
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
|
|
|