CLEARVIEW IM— 510(k) K981946

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K981946 for CLEARVIEW IM, Substantially Equivalent on 1998-12-10. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1998-06-03
Decision date: 1998-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, 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.