SPIFE A1AT kit— 510(k) K213396

Substantially Equivalent

Helena Laboratories, Corp.

FDA 510(k) clearance K213396 for SPIFE A1AT kit, Substantially Equivalent on 2022-10-13. Applicant: Helena Laboratories, Corp.. Device class: 2.

Clearance details

Applicant: Helena Laboratories, Corp.
Product code: Code OBZ
Device class: Class 2
Regulation: 21 CFR 866.5130
Advisory panel: Immunology
Date received: 2021-10-18
Decision date: 2022-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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