TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL— 510(k) K914511

Name: FDA 510(k) clearance K914511
Creator: U.S. Food and Drug Administration
Published: 1991-11-27

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K914511 for TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL, Substantially Equivalent on 1991-11-27. Applicant: Technicon Instruments Corp.. Device class: 1.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1991-10-09
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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