LUPO-TEST REAGENT— 510(k) K903037

Substantially Equivalent

Gradipore , Ltd.

FDA 510(k) clearance K903037 for LUPO-TEST REAGENT, Substantially Equivalent on 1990-12-17. 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: 1990-07-11
Decision date: 1990-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pyrmont, AU

Download summary PDF View on FDA.gov ↗

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