DeviceClearance

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

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.

Clearance details

Applicant
Helena Laboratories
Product code
Code JHO
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Beaumont, TX, US
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