IMMPULSE THEOPHYLLINE ASSAY REAGENTS— 510(k) K840758

Name: FDA 510(k) clearance K840758
Creator: U.S. Food and Drug Administration
Published: 1984-04-04

Substantially Equivalent

Paragon Diagnostics, Inc.

FDA 510(k) clearance K840758 for IMMPULSE THEOPHYLLINE ASSAY REAGENTS, Substantially Equivalent on 1984-04-04. Applicant: Paragon Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Paragon Diagnostics, Inc.
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1984-02-23
Decision date: 1984-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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