TDX NETILMICIN— 510(k) K821698

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K821698 for TDX NETILMICIN, Substantially Equivalent on 1982-06-22. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCE
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1982-06-08
Decision date: 1982-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCE

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K832088 — AMES TDA NETILMICIN TEST & SERUM1983-10-28
K822941 — NETILMICIN FLUORESCENT IMMUNOASSAY1982-10-26
K821399 — MACRO-VUE CARD TEST, NETILMICIN1982-05-28
K820324 — EMIT AND NETILMICIN ASSAY1982-02-23

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