MRI GENTAMICIN RIA KIT— 510(k) K812394

Name: FDA 510(k) clearance K812394
Creator: U.S. Food and Drug Administration
Published: 1981-09-08

Substantially Equivalent

Microanalytic Research, Inc.

FDA 510(k) clearance K812394 for MRI GENTAMICIN RIA KIT, Substantially Equivalent on 1981-09-08. Applicant: Microanalytic Research, Inc.. Device class: 2.

Clearance details

Applicant: Microanalytic Research, Inc.
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1981-08-20
Decision date: 1981-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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