Device Classification Name |
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
More FDA Info for this Device |
510(K) Number |
K040327 |
Device Name |
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter |
Applicant |
ACCU-STAT DIAGNOSTICS, INC.
11 ORCHARD RD., SUITE 108
LAKE FOREST, CA 92630 US
Other 510(k) Applications for this Company
|
Contact |
JAMES G BARRONS
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 |
02/10/2004 |
Decision Date |
04/19/2004 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
- |
Review Advisory Committee |
TX - Clinical Toxicology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|