Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device |
510(K) Number |
K182328 |
Device Name |
Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant |
True Diagnostics, Inc.
2782 Loker Ave West
Carlsbad, CA 92010 US
Other 510(k) Applications for this Company
|
Contact |
Jerry Lee
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 |
08/27/2018 |
Decision Date |
05/15/2019 |
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 |
|