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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 St.
Suite 115a
San Diego,  CA  92109
Applicant Contact JAMES SNIDER
Correspondent
Critical Care Diagnostics, Inc. (Dba Critical Diag
3030 Bunker Hill St.
Suite 115a
San Diego,  CA  92109
Correspondent Contact JAMES SNIDER
Regulation Number862.1117
Classification Product Code
OYG  
Subsequent Product Code
JJX  
Date Received05/25/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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