AMIKACIN ANALYTICAL TEST PACK ACA— 510(k) K843211

Name: FDA 510(k) clearance K843211
Creator: U.S. Food and Drug Administration
Published: 1984-09-12

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K843211 for AMIKACIN ANALYTICAL TEST PACK ACA, Substantially Equivalent on 1984-09-12. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1984-08-15
Decision date: 1984-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.