TOTAL BILIRUBIN REAGENT— 510(k) K840486

Name: FDA 510(k) clearance K840486
Creator: U.S. Food and Drug Administration
Published: 1984-04-25

Substantially Equivalent

Somas Medical Industries, Inc.

FDA 510(k) clearance K840486 for TOTAL BILIRUBIN REAGENT, Substantially Equivalent on 1984-04-25. Applicant: Somas Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: Somas Medical Industries, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1984-02-06
Decision date: 1984-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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