Device Classification Name |
Cytochrome P450 2c9 (Cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
|
510(k) Number |
K073720 |
Device Name |
ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT |
Applicant |
OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE. |
PASADENA,
CA
91105
|
|
Applicant Contact |
ROBERT DICHECK |
Correspondent |
OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE. |
PASADENA,
CA
91105
|
|
Correspondent Contact |
ROBERT DICHECK |
Regulation Number | 862.3360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/31/2007 |
Decision Date | 07/17/2008 |
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
|