FDA 510(k) Applications for Medical Device Product Code: OBZ (Alpha-1-Antitrypsin Kit, Qualitative Phenotype)

FDA 510(k) Applications for Medical Device Product Code "OBZ"
(Alpha-1-Antitrypsin Kit, Qualitative Phenotype)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K213396	Helena Laboratories, Corp.	SPIFE A1AT kit	10/13/2022
K063498	SEBIA	HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)	06/11/2007