Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K131993 |
Device Name |
MULTICHEM U |
Applicant |
TECHNO-PATH MANUFACTURING LTD. |
325 BIG ELM ST. |
HIGHLAND VILLAGE,
TX
75077
|
|
Applicant Contact |
STEPHANIE G GARTH |
Correspondent |
TECHNO-PATH MANUFACTURING LTD. |
325 BIG ELM ST. |
HIGHLAND VILLAGE,
TX
75077
|
|
Correspondent Contact |
STEPHANIE G GARTH |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 06/28/2013 |
Decision Date | 10/15/2013 |
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
|
|
|