TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH— 510(k) K850250

Name: FDA 510(k) clearance K850250
Creator: U.S. Food and Drug Administration
Published: 1985-04-01

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K850250 for TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH, Substantially Equivalent on 1985-04-01. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code JPK
Device class: Class 2
Regulation: 21 CFR 864.8625
Advisory panel: Hematology
Date received: 1985-01-22
Decision date: 1985-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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