|
Document Number | K131811 |
Test Name | UCP Biosciences, Inc., UCP Compact Drug Test Cups |
Manufacturer Name | UCP BIOSCIENCES, INC. |
Consumer Information Phone Number | (877)474-4097 |
Test Type | Phencyclidine (PCP) |
Effective Date | 11/25/2015 |
| |
Device Classification Name |
Enzyme Immunoassay, Amphetamine
|
510(k) Number |
K131811 |
Device Name |
UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS |
Applicant |
UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 |
SAN JOSE,
CA
95112
|
|
Applicant Contact |
NANCY CHEN |
Correspondent |
UCP BIOSCIENCES, INC. |
1445 KOLL CIRCLE, STE. 111 |
SAN JOSE,
CA
95112
|
|
Correspondent Contact |
NANCY CHEN |
Regulation Number | 862.3100
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/19/2013 |
Decision Date | 07/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Toxicology
|
Statement |
Statement
|
FDA Review |
Decision Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|
|