PRESAGE ST2 ASSAY


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

Correspodent Contact james snider
Regulation Number 862.1117
Classification Product Code
OYG  
Subsequent Product Code
JJX  
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