FDA 510(k) Application Details - K223867

Device Classification Name	Radioimmunoassay, Acth   More FDA Info for this Device
510(K) Number	K223867
Device Name	Radioimmunoassay, Acth
Applicant	Immunodiagnostic Systems Limited 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	862.1025   More FDA Info for this Regulation Number
Classification Product Code	CKG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2022
Decision Date	08/18/2023
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