Device Classification Name |
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
|
510(k) Number |
K010655 |
Device Name |
AT HOME DRUG TESTT, MODEL 9150 T |
Applicant |
PHAMATECH |
9530 PADGETT ST. #101 |
SAN DIEGO,
CA
92126
|
|
Applicant Contact |
CARL A MONGIOVI |
Correspondent |
PHAMATECH |
9530 PADGETT ST. #101 |
SAN DIEGO,
CA
92126
|
|
Correspondent Contact |
CARL A MONGIOVI |
Classification Product Code |
|
Date Received | 03/05/2001 |
Decision Date | 04/05/2001 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Toxicology
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|