FDA 510(k) Application Details - K950481

Device Classification Name	Enzymatic Methods, Galactose   More FDA Info for this Device
510(K) Number	K950481
Device Name	Enzymatic Methods, Galactose
Applicant	ISOLAB, INC. BOX 4350 AKRON, OH 44321 US Other 510(k) Applications for this Company
Contact	JANET PERKINS Other 510(k) Applications for this Contact
Regulation Number	862.1310   More FDA Info for this Regulation Number
Classification Product Code	JIA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/1995
Decision Date	02/01/1996
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