FDA 510(k) Application Details - K003584

Device Classification Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   More FDA Info for this Device
510(K) Number	K003584
Device Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant	MICROMASS, INC. 34 MAPLE ST. MILFORD, MA 01757 US Other 510(k) Applications for this Company
Contact	DANIEL J DILLON Other 510(k) Applications for this Contact
Regulation Number	862.1555   More FDA Info for this Regulation Number
Classification Product Code	JNB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2000
Decision Date	03/19/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review