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510(k) K213396

Device
SPIFE A1AT Kit
Applicant
Helena Laboratories, Corp.
510(k) number
K213396
Product code
OBZ  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-13
Date received
2021-10-18
Regulation
866.5130
Classification name
Alpha-1-antitrypsin Kit, Qualitative Phenotype
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Rachel Easley
Address
1530 Lindbergh Dr. Beaumont TX US 77707 77707

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OBZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063498HYDRAGEL 18 A1AT ISOFOCUSING KIT (PN 4356)Sebia2007-06-11

Legacy Summary#

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FDA Review#

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