IMMUNO DIAGNOSTICS ASSAY— 510(k) K822026

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K822026 for IMMUNO DIAGNOSTICS ASSAY, Substantially Equivalent on 1982-08-03. Applicant: Helena Laboratories.

Clearance details

Applicant: Helena Laboratories
Product code: Code CZP
Advisory panel: Immunology
Date received: 1982-07-12
Decision date: 1982-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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