AMIKACIN FLUORESCENT IMMUNOASSAY— 510(k) K813541

Name: FDA 510(k) clearance K813541
Creator: U.S. Food and Drug Administration
Published: 1982-01-12

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K813541 for AMIKACIN FLUORESCENT IMMUNOASSAY, Substantially Equivalent on 1982-01-12. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 1981-12-21
Decision date: 1982-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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