Device Classification Name |
diazo colorimetry, bilirubin
|
510(k) Number |
K131544 |
Device Name |
COBAS C BILIRUBIN TOTAL GEN.3 |
Applicant |
Roche Diagnostics |
9115 SOUTH HAGUE ROAD |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
LISA K KLINEDINST |
Correspondent |
Roche Diagnostics |
9115 SOUTH HAGUE ROAD |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
LISA K KLINEDINST |
Regulation Number | 862.1110
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/29/2013 |
Decision Date | 07/17/2013 |
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
|
|
|