UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON.— 510(k) K871115

Name: FDA 510(k) clearance K871115
Creator: U.S. Food and Drug Administration
Published: 1989-01-27

Substantially Equivalent

Labo Science-USA, Inc.

FDA 510(k) clearance K871115 for UB ANALYZER, MODEL UA-1/REAGENT KIT/BILIRUBIN CON., Substantially Equivalent on 1989-01-27. Applicant: Labo Science-USA, Inc.. Device class: 2.

Clearance details

Applicant: Labo Science-USA, Inc.
Product code: Code CIG
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 1987-03-19
Decision date: 1989-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Briarcliff Manor, NY, US

Download summary PDF View on FDA.gov ↗

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