FDA 510(k) Application Details - K190335

Device Classification Name	Enzymatic Methods, Galactose   More FDA Info for this Device
510(K) Number	K190335
Device Name	Enzymatic Methods, Galactose
Applicant	PerkinElmer Inc. 940 Winter Street Waltham, MA 02451 US Other 510(k) Applications for this Company
Contact	Brian Ciccariello 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	02/14/2019
Decision Date	11/06/2019
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