FDA 510(k) Application Details - K021541

Device Classification Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   More FDA Info for this Device
510(K) Number	K021541
Device Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant	PERKINELMER LIFE SCIENCES 3985 EASTERN RD. NORTON, OH 44203 US Other 510(k) Applications for this Company
Contact	HANK JUSKE 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	05/10/2002
Decision Date	10/28/2002
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