FDA 510(k) Application Details - K211667

Device Classification Name	N-Acetylprocainamide Control Materials   More FDA Info for this Device
510(K) Number	K211667
Device Name	N-Acetylprocainamide Control Materials
Applicant	Changzhou Universal Medical Equipment Co. Ltd No. 6, Xinxi Road, Xinbei District Changzhou 213000 CN Other 510(k) Applications for this Company
Contact	Jerry Gao Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	LAZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2021
Decision Date	09/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review