Device Classification Name |
test, factor v leiden mutations, genomic dna pcr
|
510(k) Number |
K060564 |
Device Name |
INFINITI SYSTEM |
Applicant |
AUTOGENOMICS, INC |
2251 RUTHERFORD ROAD |
CARLSBAD,
CA
92008
|
|
Applicant Contact |
EVELYN LOPEZ |
Correspondent |
AUTOGENOMICS, INC |
2251 RUTHERFORD ROAD |
CARLSBAD,
CA
92008
|
|
Correspondent Contact |
EVELYN LOPEZ |
Regulation Number | 864.7280
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/03/2006 |
Decision Date | 02/07/2007 |
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
|
|
|