FDA 510(k) Application Details - K943367

Device Classification Name	Colorimetry, Cholinesterase   More FDA Info for this Device
510(K) Number	K943367
Device Name	Colorimetry, Cholinesterase
Applicant	INSTRUMENTATION LABORATORY CO. 101 HARTWELL AVE. LEXINGTON, MA 02173 US Other 510(k) Applications for this Company
Contact	WALLIS W CADY Other 510(k) Applications for this Contact
Regulation Number	862.3240   More FDA Info for this Regulation Number
Classification Product Code	DIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/1994
Decision Date	02/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review