FDA 510(k) Application Details - K240468

Device Classification Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes   More FDA Info for this Device
510(K) Number	K240468
Device Name	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant	Abbott Laboratories Diagnostics Division 1915 Hurd Drive Department RA11, Building LC 8 - 4th Floor MS 8-9 Irving, TX 75038 US Other 510(k) Applications for this Company
Contact	Bryant Tate Other 510(k) Applications for this Contact
Regulation Number	862.1050   More FDA Info for this Regulation Number
Classification Product Code	CJE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/20/2024
Decision Date	10/16/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review