AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM— 510(k) K820397

Name: FDA 510(k) clearance K820397
Creator: U.S. Food and Drug Administration
Published: 1982-03-02

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K820397 for AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM, Substantially Equivalent on 1982-03-02. Applicant: American Diagnostic Corp.. Device class: 2.

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1982-02-11
Decision date: 1982-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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