FDA 510(k) Application Details - K023046

Device Classification Name	Stains, Chemical Solution   More FDA Info for this Device
510(K) Number	K023046
Device Name	Stains, Chemical Solution
Applicant	SINCLAIR PHARMACEUTICALS, LTD. BOROUGH RD. GODALMING, SURREY GU7 2AB GB Other 510(k) Applications for this Company
Contact	DENISE SWIFT Other 510(k) Applications for this Contact
Regulation Number	864.1850   More FDA Info for this Regulation Number
Classification Product Code	LED Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2002
Decision Date	12/02/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review