TECHNICON H*1 SYSTEM (HDW)— 510(k) K853030

Name: FDA 510(k) clearance K853030
Creator: U.S. Food and Drug Administration
Published: 1986-02-05

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K853030 for TECHNICON H*1 SYSTEM (HDW), Substantially Equivalent on 1986-02-05. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code GKL
Device class: Class 2
Regulation: 21 CFR 864.5200
Advisory panel: Hematology
Date received: 1985-07-18
Decision date: 1986-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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