GEN PROFILER SYSTEM— 510(k) K851619

Substantially Equivalent

Electro-Cucleonics, Inc.

FDA 510(k) clearance K851619 for GEN PROFILER SYSTEM, Substantially Equivalent on 1985-05-14. Applicant: Electro-Cucleonics, Inc.. Device class: 1.

Clearance details

Applicant: Electro-Cucleonics, Inc.
Product code: Code JJG
Device class: Class 1
Regulation: 21 CFR 862.2140
Advisory panel: Clinical Chemistry
Date received: 1985-04-18
Decision date: 1985-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.