FDA 510(k) Application Details - K960095

Device Classification Name	Stains, Microbiologic   More FDA Info for this Device
510(K) Number	K960095
Device Name	Stains, Microbiologic
Applicant	REMEL CO. 12076 SANTA FE DR. LENEXA, KS 66215 US Other 510(k) Applications for this Company
Contact	MARY ANN SLIVIUS Other 510(k) Applications for this Contact
Regulation Number	864.1850   More FDA Info for this Regulation Number
Classification Product Code	JTS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/11/1996
Decision Date	03/19/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review