Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device |
510(K) Number |
K953606 |
Device Name |
Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant |
AMERITEK, INC.
7030 35TH AVE., N.E.
SEATTLE, WA 98115 US
Other 510(k) Applications for this Company
|
Contact |
H C YEE
Other 510(k) Applications for this Contact |
Regulation Number |
862.1155
More FDA Info for this Regulation Number |
Classification Product Code |
LCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
08/02/1995 |
Decision Date |
03/22/1996 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|