FDA 510(k) Application Details - K002049

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K002049
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	SELFCARE, INC. 200 PROSPECT ST. WALTHAM, MA 02154-3457 US Other 510(k) Applications for this Company
Contact	CAROL A ADILETTO 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	07/03/2000
Decision Date	07/27/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review