PRIMIDONE FLUORESCENT IMMUNOASSAY— 510(k) K822229

Name: FDA 510(k) clearance K822229
Creator: U.S. Food and Drug Administration
Published: 1982-08-12

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K822229 for PRIMIDONE FLUORESCENT IMMUNOASSAY, Substantially Equivalent on 1982-08-12. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code LFT
Device class: Class 2
Regulation: 21 CFR 862.3680
Advisory panel: Clinical Toxicology
Date received: 1982-07-27
Decision date: 1982-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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