FDA 510(k) Application Details - K981926

Device Classification Name	Calibrators, Drug Specific   More FDA Info for this Device
510(K) Number	K981926
Device Name	Calibrators, Drug Specific
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	DLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/02/1998
Decision Date	07/22/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review