Device Classification Name |
Multi-Analyte Controls, All Kinds (Assayed)
|
510(k) Number |
K110616 |
Device Name |
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO |
Applicant |
MICROGENICS CORP. |
46360 FREMONT BLVD |
FREMONT,
CA
94538
|
|
Applicant Contact |
LISA CHARTER |
Correspondent |
MICROGENICS CORP. |
46360 FREMONT BLVD |
FREMONT,
CA
94538
|
|
Correspondent Contact |
LISA CHARTER |
Regulation Number | 862.1660
|
Classification Product Code |
|
Date Received | 03/03/2011 |
Decision Date | 06/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|