ELECSYS MYOGLOBIN CALCHECK 5


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K112113
Device Name ELECSYS MYOGLOBIN CALCHECK 5
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Applicant Contact kelly colleen o’maine adams
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250 -0416

Correspodent Contact kelly colleen o’maine adams
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 07/25/2011
Decision Date 09/14/2011
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