510(k) K213396

SPIFE A1AT kit by Helena Laboratories, Corp. — Product Code OBZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 13, 2022
Date Received: October 18, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Alpha-1-Antitrypsin Kit, Qualitative Phenotype
Device Class: Class II
Regulation Number: 866.5130
Review Panel: IM
Submission Type

The alpha-1-antitrypsin qualitative phenotype test result is used as an aid in the diagnosis of alpha-1-antitrypsin deficiency in conjunction with clinical and other laboratory findings. For in vitro diagnostic use only.

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510(k) K213396

Clearance Details

Device Classification

Other clearances by Helena Laboratories, Corp.

Other clearances for product code OBZ