AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1— 510(k) K863719

Name: FDA 510(k) clearance K863719
Creator: U.S. Food and Drug Administration
Published: 1986-11-13

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K863719 for AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1, Substantially Equivalent on 1986-11-13. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CIJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1986-09-23
Decision date: 1986-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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