MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL— 510(k) K855227

Name: FDA 510(k) clearance K855227
Creator: U.S. Food and Drug Administration
Published: 1986-04-11

Substantially Equivalent

Bioclinical Systems, Inc.

FDA 510(k) clearance K855227 for MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL, Substantially Equivalent on 1986-04-11. Applicant: Bioclinical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Bioclinical Systems, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1985-12-30
Decision date: 1986-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, US

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