Device Classification Name |
Test, Factor V Leiden Mutations, Genomic Dna Pcr
|
510(k) Number |
K082118 |
Device Name |
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY |
Applicant |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Applicant Contact |
RUSSEL K ENNS |
Correspondent |
CEPHEID |
904 CARIBBEAN DRIVE |
SUNNYVALE,
CA
94089 -1189
|
|
Correspondent Contact |
RUSSEL K ENNS |
Regulation Number | 864.7280
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/28/2008 |
Decision Date | 09/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|