AMIKACIN REAGENT TEST KIT— 510(k) K840647

Name: FDA 510(k) clearance K840647
Creator: U.S. Food and Drug Administration
Published: 1984-04-02

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K840647 for AMIKACIN REAGENT TEST KIT, Substantially Equivalent on 1984-04-02. Applicant: Beckman Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code LDN
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1984-02-15
Decision date: 1984-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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