Device Classification Name |
Assay, Porphyrin, Spectrophotometry, Lithium
|
510(k) Number |
K063684 |
Device Name |
COBAS LITHIUM |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
THERESA AMBROSE BUSH |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
THERESA AMBROSE BUSH |
Regulation Number | 862.3560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/12/2006 |
Decision Date | 03/21/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|