CARBAMAZEPINE FLOURESCENT IMMUNOASSAY— 510(k) K821945

Name: FDA 510(k) clearance K821945
Creator: U.S. Food and Drug Administration
Published: 1982-07-16

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K821945 for CARBAMAZEPINE FLOURESCENT IMMUNOASSAY, Substantially Equivalent on 1982-07-16. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1982-06-29
Decision date: 1982-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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