Device Classification Name |
Drug Metabolizing Enzyme Genotyping Systems
|
510(k) Number |
K123891 |
Device Name |
SPARTAN RX CYP2C19 TEST SYSTEM |
Applicant |
SPARTAN BIOSCIENCE INC |
3 LAGOON DRIVE, STE 280 |
REDWOOD SHORES,
CA
94065
|
|
Applicant Contact |
LORRY HUFFMAN |
Correspondent |
SPARTAN BIOSCIENCE INC |
3 LAGOON DRIVE, STE 280 |
REDWOOD SHORES,
CA
94065
|
|
Correspondent Contact |
LORRY HUFFMAN |
Regulation Number | 862.3360
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/18/2012 |
Decision Date | 08/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Abbreviated
|
Clinical Trials |
NCT01676298 NCT01718535
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|