Device Classification Name |
enzyme immunoassay, amphetamine
|
510(k) Number |
K091588 |
Device Name |
UCP HOME DRUG SCREENING TESTS |
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 | 06/02/2009 |
Decision Date | 09/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Toxicology
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|