Device Classification Name |
Radioimmunoassay, Vancomycin
|
510(k) Number |
K060586 |
Device Name |
ENZYME IMMUNOASSAY, VANCOMYCIN |
Applicant |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Applicant Contact |
DIMITRIS DEMIRTZOGLOU |
Correspondent |
ROCHE DIAGNOSTICS CORP. |
9115 HAGUE RD. |
INDIANAPOLIS,
IN
46250
|
|
Correspondent Contact |
DIMITRIS DEMIRTZOGLOU |
Regulation Number | 862.3950
|
Classification Product Code |
|
Date Received | 03/07/2006 |
Decision Date | 05/11/2006 |
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
|
Recalls |
CDRH Recalls
|
|
|