MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123— 510(k) K012789

Name: FDA 510(k) clearance K012789
Creator: U.S. Food and Drug Administration
Published: 2002-01-17

Substantially Equivalent

Morax

FDA 510(k) clearance K012789 for MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123, Substantially Equivalent on 2002-01-17. Applicant: Morax. Device class: 1.

Clearance details

Applicant: Morax
Product code: Code JHO
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2001-08-20
Decision date: 2002-01-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Chelsea, MI, US

Download summary PDF View on FDA.gov ↗

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