FDA 510(k) Application Details - K213396

Device Classification Name	Alpha-1-Antitrypsin Kit, Qualitative Phenotype   More FDA Info for this Device
510(K) Number	K213396
Device Name	Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Applicant	Helena Laboratories, Corp. 1530 Lindbergh Drive Beaumont, TX 77707 US Other 510(k) Applications for this Company
Contact	Rachel Easley Other 510(k) Applications for this Contact
Regulation Number	866.5130   More FDA Info for this Regulation Number
Classification Product Code	OBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2021
Decision Date	10/13/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review