GENTAMICIN FLUROIMMUNASSAY KIT— 510(k) K782025

Name: FDA 510(k) clearance K782025
Creator: U.S. Food and Drug Administration
Published: 1979-01-26

Substantially Equivalent

Technia Diagnostics , Ltd.

FDA 510(k) clearance K782025 for GENTAMICIN FLUROIMMUNASSAY KIT, Substantially Equivalent on 1979-01-26. Applicant: Technia Diagnostics , Ltd.. Device class: 2.

Clearance details

Applicant: Technia Diagnostics , Ltd.
Product code: Code LCQ
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1978-12-05
Decision date: 1979-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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