TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES— 510(k) K902243

Name: FDA 510(k) clearance K902243
Creator: U.S. Food and Drug Administration
Published: 1990-07-05

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K902243 for TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES, Substantially Equivalent on 1990-07-05. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1990-05-18
Decision date: 1990-07-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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