FDA 510(k) Application Details - K973995

Device Classification Name	Hemoglobinometer   More FDA Info for this Device
510(K) Number	K973995
Device Name	Hemoglobinometer
Applicant	RANDOX LABORATORIES, LTD. ARDMORE, DIAMOND ROAD CRUMLIN BT29 4QY IE Other 510(k) Applications for this Company
Contact	P ARMSTRONG Other 510(k) Applications for this Contact
Regulation Number	864.7500   More FDA Info for this Regulation Number
Classification Product Code	GIG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/21/1997
Decision Date	12/08/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review