Device Classification Name |
c. difficile nucleic acid amplification test assay
|
510(k) Number |
K113433 |
Device Name |
SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT |
Applicant |
FOCUS DIAGNOSTICS, INC. |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Applicant Contact |
SHARON YOUNG |
Correspondent |
FOCUS DIAGNOSTICS, INC. |
11331 Valley View Street |
CYPRESS,
CA
90630
|
|
Correspondent Contact |
SHARON YOUNG |
Regulation Number | 866.2660
|
Classification Product Code |
|
Date Received | 11/21/2011 |
Decision Date | 04/04/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Microbiology
|
510k Review Panel |
Microbiology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|