Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device |
510(K) Number |
K053236 |
Device Name |
Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant |
RUNBIO BIOTECH CO., LTD.
2941 61ST. AVE NE
TACOMA, WA 98422 US
Other 510(k) Applications for this Company
|
Contact |
JESSICA VAGATA
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 |
11/18/2005 |
Decision Date |
07/18/2006 |
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 |
|