FDA 510(k) Application Details - K200475

Device Classification Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes   More FDA Info for this Device
510(K) Number	K200475
Device Name	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Applicant	Immunodiagnostic Systems Ltd. 10 Didcot Way, Boldon Business Park Boldon NE35 9PD GB Other 510(k) Applications for this Company
Contact	Mick Henderson Other 510(k) Applications for this Contact
Regulation Number	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CIN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/26/2020
Decision Date	09/30/2020
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