Device Classification Name |
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
|
510(k) Number |
K142129 |
Device Name |
RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID COCAINE CALIBRATOR SET, RAPIDFRET ORAL FLUID COCAINE CONTROL SET |
Applicant |
BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
NATAHANIEL G BUTLIN |
Correspondent |
BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
NATAHANIEL G BUTLIN |
Regulation Number | 862.3250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/04/2014 |
Decision Date | 07/24/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|