RAPIDPOINT 405 NEONATAL BILIRUBIN


Device Classification Name

bilirubin (total and unbound) in the neonate test system

510(k) Number K110277
Device Name RAPIDPOINT 405 NEONATAL BILIRUBIN
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
2 edgewater drive
norwood, 
MA 
02062

Applicant Contact steven goldberg
Correspondent
SIEMENS HEALTHCARE DIAGNOSTICS
2 edgewater drive
norwood, 
MA 
02062

Correspodent Contact steven goldberg
Regulation Number 862.1113
Classification Product Code
MQM  
Date Received 01/31/2011
Decision Date 08/15/2011
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

Recalls CDRH Recalls