TOTAL BILIRUBIN REAGENT SET— 510(k) K910635

Name: FDA 510(k) clearance K910635
Creator: U.S. Food and Drug Administration
Published: 1991-05-15

Substantially Equivalent

Biochemical Trade, Inc.

FDA 510(k) clearance K910635 for TOTAL BILIRUBIN REAGENT SET, Substantially Equivalent on 1991-05-15. Applicant: Biochemical Trade, Inc.. Device class: 2.

Clearance details

Applicant: Biochemical Trade, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1991-02-12
Decision date: 1991-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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