GEMENI IGM ASSAY— 510(k) K800450

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K800450 for GEMENI IGM ASSAY, Substantially Equivalent on 1980-04-24. Applicant: Electro-Nucleonics Laboratories, Inc..

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code DAO
Advisory panel: Immunology
Date received: 1980-02-29
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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