IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM— 510(k) K911060

Name: FDA 510(k) clearance K911060
Creator: U.S. Food and Drug Administration
Published: 1991-05-08

Substantially Equivalent

Immunomatrix

FDA 510(k) clearance K911060 for IMMUNOMATRIX THEOPHYLINE ASSAY SYSTEM, Substantially Equivalent on 1991-05-08. Applicant: Immunomatrix. Device class: 2.

Clearance details

Applicant: Immunomatrix
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1991-03-11
Decision date: 1991-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, US

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