Device Classification Name |
Test, Factor V Leiden Mutations, Genomic Dna Pcr
|
510(k) Number |
K093129 |
Device Name |
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II |
Applicant |
ILLUMINA, INC. |
9865 TOWNE CENTRE DRIVE |
SAN DIEGO,
CA
92121 -1975
|
|
Applicant Contact |
DONALD R ELLIS |
Correspondent |
ILLUMINA, INC. |
9865 TOWNE CENTRE DRIVE |
SAN DIEGO,
CA
92121 -1975
|
|
Correspondent Contact |
DONALD R ELLIS |
Regulation Number | 864.7280
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/02/2009 |
Decision Date | 04/28/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Pathology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00959504
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|