TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES— 510(k) K912616

Name: FDA 510(k) clearance K912616
Creator: U.S. Food and Drug Administration
Published: 1991-09-25

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K912616 for TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES, Substantially Equivalent on 1991-09-25. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1991-06-13
Decision date: 1991-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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