FDA 510(k) Application Details - K992232

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K992232
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 CRANBURY, NJ 08512 US Other 510(k) Applications for this Company
Contact	Maureen Garner 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	07/02/1999
Decision Date	12/21/1999
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