KENAMYCIN FLUORESCENT IMMUNOASSAY FIA— 510(k) K823062

Name: FDA 510(k) clearance K823062
Creator: U.S. Food and Drug Administration
Published: 1982-11-10

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K823062 for KENAMYCIN FLUORESCENT IMMUNOASSAY FIA, Substantially Equivalent on 1982-11-10. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code KJI
Device class: Class 2
Regulation: 21 CFR 862.3520
Advisory panel: Clinical Toxicology
Date received: 1982-10-18
Decision date: 1982-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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