Device Classification Name |
Enzyme Immunoassay, Phencyclidine
|
510(k) Number |
K122703 |
Device Name |
RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR |
Applicant |
BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
Nathaniel G Butlin |
Correspondent |
BIOPHOR DIAGNOSTICS, INC. |
1201 DOUGLAS AVE |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
Nathaniel G Butlin |
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/04/2012 |
Decision Date | 04/25/2013 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Toxicology
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|