FDA 510(k) Application Details - K955903

Device Classification Name	Kit, Test, Pregnancy, Hcg, Over The Counter   More FDA Info for this Device
510(K) Number	K955903
Device Name	Kit, Test, Pregnancy, Hcg, Over The Counter
Applicant	CAMBRIDGE DIAGNOSTICS IRELAND, LTD. MERVUE BUSINESS PARK GALWAY IE Other 510(k) Applications for this Company
Contact	KATHLEEN M ,CLOUGH 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	12/29/1995
Decision Date	03/06/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review