Device Classification Name |
Kit, Test, Pregnancy, Hcg, Over The Counter
More FDA Info for this Device |
510(K) Number |
K011551 |
Device Name |
Kit, Test, Pregnancy, Hcg, Over The Counter |
Applicant |
Chembio Diagnostic Systems, Inc.
163 CABOT ST.
BEVERLY,, MA 01915 US
Other 510(k) Applications for this Company
|
Contact |
FRAN WHITE
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 |
05/18/2001 |
Decision Date |
08/14/2001 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
CH - Clinical Chemistry |
Review Advisory Committee |
CH - Clinical Chemistry |
Statement / Summary / Purged Status |
Statement |
Type |
Special |
Reviewed By Third Party |
N |
Expedited Review |
|