NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265


Device Classification Name

bilirubin (total and unbound) in the neonate test system

510(k) Number K073537
Device Name NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
Applicant
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
2 edgewater dr.
norwood, 
MA 
02062

Applicant Contact noor malki
Correspondent
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
2 edgewater dr.
norwood, 
MA 
02062

Correspodent Contact noor malki
Regulation Number 862.1113
Classification Product Code
MQM  
Date Received 12/17/2007
Decision Date 06/27/2008
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