TURBOX THEOPHYLLINE ASSAY— 510(k) K882570

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K882570 for TURBOX THEOPHYLLINE ASSAY, Substantially Equivalent on 1988-11-10. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code LER
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1988-06-22
Decision date: 1988-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford Mk41 Oqg, GB

Download summary PDF View on FDA.gov ↗

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