FDA 510(k) Application Details - DEN180056

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN180056
Device Name	GSP Neonatal Creatine Kinase - MM kit
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	More FDA Info for this Regulation Number
Classification Product Code	QJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/11/2018
Decision Date	12/12/2019
Decision	DENG -
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review