FDA 510(k) Application Details - K984463

Device Classification Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   More FDA Info for this Device
510(K) Number	K984463
Device Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant	QUANTASE LTD. 3 RIVERVIEW BUSINESS PARK FRIARTON ROAD PERTH, SCOTLAND PH2 8DF GB Other 510(k) Applications for this Company
Contact	R. STEWART CAMPBELL 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	12/16/1998
Decision Date	02/16/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review