Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K162530 |
Device Name |
Multichem IA Plus |
Applicant |
TECHNO-PATH MANUFACTURING |
BALLINA |
CO. TIPPERARY,
IE
|
|
Applicant Contact |
BERND HASS |
Correspondent |
TECHNO-PATH MANUFACTURING |
BALLINA |
CO. TIPPERARY,
IE
|
|
Correspondent Contact |
BERND HASS |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 09/09/2016 |
Decision Date | 03/31/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|