FDA 510(k) Application Details - K951877

Device Classification Name	Automated Urinalysis System   More FDA Info for this Device
510(K) Number	K951877
Device Name	Automated Urinalysis System
Applicant	CHIMERA RESEARCH & CHEMICAL, INC. P.O. BOX 3363 SEMINOLE, FL 33775 US Other 510(k) Applications for this Company
Contact	CHARLES A HAY Other 510(k) Applications for this Contact
Regulation Number	862.2900   More FDA Info for this Regulation Number
Classification Product Code	KQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1995
Decision Date	05/14/1996
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