GENTAMICIN TEST PACK-ACA— 510(k) K831210

Name: FDA 510(k) clearance K831210
Creator: U.S. Food and Drug Administration
Published: 1983-05-25

Substantially Equivalent

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

FDA 510(k) clearance K831210 for GENTAMICIN TEST PACK-ACA, Substantially Equivalent on 1983-05-25. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1983-04-14
Decision date: 1983-05-25
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.