USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R)— 510(k) K874506

Name: FDA 510(k) clearance K874506
Creator: U.S. Food and Drug Administration
Published: 1988-01-22

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K874506 for USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R), Substantially Equivalent on 1988-01-22. Applicant: Technicon Instruments Corp.. Device class: 1.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JGJ
Device class: Class 1
Regulation: 21 CFR 862.1495
Advisory panel: Clinical Chemistry
Date received: 1987-11-02
Decision date: 1988-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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