SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343— 510(k) K013466

Name: FDA 510(k) clearance K013466
Creator: U.S. Food and Drug Administration
Published: 2001-12-21

Substantially Equivalent

Helena Laboratories

FDA 510(k) clearance K013466 for SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343, Substantially Equivalent on 2001-12-21. Applicant: Helena Laboratories. Device class: 1.

Clearance details

Applicant: Helena Laboratories
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2001-10-18
Decision date: 2001-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beaumont, TX, US

Download summary PDF View on FDA.gov ↗

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