Device Classification Name |
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
More FDA Info for this Device |
510(K) Number |
K013412 |
Device Name |
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
Applicant |
PHAMATECH INC.
9530 PADGETT ST., #101
SAN DIEGO, CA 92126 US
Other 510(k) Applications for this Company
|
Contact |
CARL MONGIOVI
Other 510(k) Applications for this Contact |
Regulation Number |
000.0000
More FDA Info for this Regulation Number |
Classification Product Code |
MVO
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/15/2001 |
Decision Date |
12/06/2001 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
- |
Review Advisory Committee |
TX - Clinical Toxicology |
Statement / Summary / Purged Status |
Summary |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|