CLEARVIEW HCG— 510(k) K910946

Substantially Equivalent

Unipath , Ltd.

FDA 510(k) clearance K910946 for CLEARVIEW HCG, Substantially Equivalent on 1991-04-01. Applicant: Unipath , Ltd.. Device class: 2.

Clearance details

Applicant: Unipath , Ltd.
Product code: Code JHJ
Device class: Class 2
Regulation: 21 CFR 862.1155
Advisory panel: Clinical Chemistry
Date received: 1991-03-06
Decision date: 1991-04-01
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.