FDA 510(k) Application Details - K943547

Device Classification Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine   More FDA Info for this Device
510(K) Number	K943547
Device Name	Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
Applicant	ISOLAB, INC. DRAWER 4350 AKRON, OH 44321 US Other 510(k) Applications for this Company
Contact	JANET D PERKINS 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	07/21/1994
Decision Date	01/26/1996
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