Device Classification Name |
st2 assay
|
510(k) Number |
K111452 |
Device Name |
PRESAGE ST2 ASSAY |
Applicant |
CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG |
3030 BUNKER HILL STREET |
SUITE 115A |
SAN DIEGO,
CA
92109
|
|
Applicant Contact |
JAMES SNIDER |
Correspondent |
CRITICAL CARE DIAGNOSTICS, INC. (DBA CRITICAL DIAG |
3030 BUNKER HILL STREET |
SUITE 115A |
SAN DIEGO,
CA
92109
|
|
Correspondent Contact |
JAMES SNIDER |
Regulation Number | 862.1117
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/25/2011 |
Decision Date | 12/09/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00047437
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|