FDA 510(k) Application Details - K993375

Device Classification Name	Calibrator For Cell Indices   More FDA Info for this Device
510(K) Number	K993375
Device Name	Calibrator For Cell Indices
Applicant	CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 PLANTATION, FL 33313 US Other 510(k) Applications for this Company
Contact	COLIN ALDERSLEY Other 510(k) Applications for this Contact
Regulation Number	864.8150   More FDA Info for this Regulation Number
Classification Product Code	KRX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/07/1999
Decision Date	12/20/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review