ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET


Device Classification Name

acid, folic, radioimmunoassay

510(k) Number K103716
Device Name ROCHE ELECSYS FOLATE RBC; ROCHE ELECSYS FOLATE RBC CALSET
Applicant
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250

Applicant Contact kathie j goodwin
Correspondent
Roche Diagnostics
9115 hague road
indianapolis, 
IN 
46250

Correspodent Contact kathie j goodwin
Regulation Number 862.1295
Classification Product Code
CGN  
Subsequent Product Codes
JIT   JJX  
Date Received 12/21/2010
Decision Date 05/12/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No