DIAZO, COLORIMETRIC BILIRUBIN— 510(k) K882459

Name: FDA 510(k) clearance K882459
Creator: U.S. Food and Drug Administration
Published: 1988-08-02

Substantially Equivalent

Tech-Neal Scientific, Inc.

FDA 510(k) clearance K882459 for DIAZO, COLORIMETRIC BILIRUBIN, Substantially Equivalent on 1988-08-02. Applicant: Tech-Neal Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Tech-Neal Scientific, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1988-06-15
Decision date: 1988-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.