FDA 510(k) Application Details - K973054

Device Classification Name	Calibrators, Ethyl Alcohol   More FDA Info for this Device
510(K) Number	K973054
Device Name	Calibrators, Ethyl Alcohol
Applicant	EMD CHEMICALS INC. 480 DEMOCRAT RD. GIBBSTOWN, NJ 08027 US Other 510(k) Applications for this Company
Contact	ANNA G BENTLEY Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DNN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/15/1997
Decision Date	10/01/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review