LUCOR CONFIRMATORY REAGENT— 510(k) K922156

Substantially Equivalent

Gradipore , Ltd.

FDA 510(k) clearance K922156 for LUCOR CONFIRMATORY REAGENT, Substantially Equivalent on 1993-04-06. Applicant: Gradipore , Ltd.. Device class: 1.

Clearance details

Applicant: Gradipore , Ltd.
Product code: Code GIR
Device class: Class 1
Regulation: 21 CFR 864.8950
Advisory panel: Hematology
Date received: 1992-05-07
Decision date: 1993-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyrmont, AU

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