Device Classification Name |
test, factor v leiden mutations, genomic dna pcr
|
510(k) Number |
K093974 |
Device Name |
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING |
Applicant |
OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE. |
PASADENA,
CA
91105
|
|
Applicant Contact |
ROBERT S DICHECK |
Correspondent |
OSMETECH MOLECULAR DIAGNOSTICS |
757 SOUTH RAYMOND AVE. |
PASADENA,
CA
91105
|
|
Correspondent Contact |
ROBERT S DICHECK |
Regulation Number | 864.7280
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/23/2009 |
Decision Date | 04/22/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|