TOTAL BILIRUBIN REAGENT SET— 510(k) K841050

Name: FDA 510(k) clearance K841050
Creator: U.S. Food and Drug Administration
Published: 1984-05-01

Substantially Equivalent

Medical Specialties, Inc.

FDA 510(k) clearance K841050 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 1984-05-01. Applicant: Medical Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Medical Specialties, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1984-03-12
Decision date: 1984-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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