ELECTROPHORESIS DATA CENTER (EDC)— 510(k) K860645

Name: FDA 510(k) clearance K860645
Creator: U.S. Food and Drug Administration
Published: 1986-12-17

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K860645 for ELECTROPHORESIS DATA CENTER (EDC), Substantially Equivalent on 1986-12-17. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JQT
Device class: Class 1
Regulation: 21 CFR 862.2400
Advisory panel: Clinical Chemistry
Date received: 1986-02-20
Decision date: 1986-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

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