FDA 510(k) Application Details - K961807

Device Classification Name	Control, Hematocrit   More FDA Info for this Device
510(K) Number	K961807
Device Name	Control, Hematocrit
Applicant	CIBA CORNING DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052-1688 US Other 510(k) Applications for this Company
Contact	William J Pignato Other 510(k) Applications for this Contact
Regulation Number	864.8625   More FDA Info for this Regulation Number
Classification Product Code	GLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/10/1996
Decision Date	07/26/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review