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
|
|
Correspondent Contact |
NOOR MALKI |
Regulation Number | 862.1113
|
Classification Product Code |
|
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
|