TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN— 510(k) K881798

Name: FDA 510(k) clearance K881798
Creator: U.S. Food and Drug Administration
Published: 1988-06-07

Substantially Equivalent

Technicon Instruments Corp.

FDA 510(k) clearance K881798 for TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN, Substantially Equivalent on 1988-06-07. Applicant: Technicon Instruments Corp.. Device class: 2.

Clearance details

Applicant: Technicon Instruments Corp.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1988-04-27
Decision date: 1988-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tarrytown, NY, US

Download summary PDF View on FDA.gov ↗

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