TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC— 510(k) K853853

Name: FDA 510(k) clearance K853853
Creator: U.S. Food and Drug Administration
Published: 1985-10-03

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K853853 for TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC, Substantially Equivalent on 1985-10-03. 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: 1985-09-16
Decision date: 1985-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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