FLUOROMATIC THEOPHYLLINE FIA— 510(k) K811856

Substantially Equivalent

Bio-Rad

FDA 510(k) clearance K811856 for FLUOROMATIC THEOPHYLLINE FIA, Substantially Equivalent on 1981-07-10. Applicant: Bio-Rad. Device class: 2.

Clearance details

Applicant: Bio-Rad
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1981-07-01
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.