GRADILEIDEN V TEST— 510(k) K992456

Substantially Equivalent

Gradipore , Ltd.

FDA 510(k) clearance K992456 for GRADILEIDEN V TEST, Substantially Equivalent on 1999-12-21. Applicant: Gradipore , Ltd.. Device class: 2.

Clearance details

Applicant: Gradipore , Ltd.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 1999-07-23
Decision date: 1999-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Ryde, AU

Download summary PDF View on FDA.gov ↗

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More clearances from Gradipore , Ltd.

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K922156 — LUCOR CONFIRMATORY REAGENT1993-04-06
K903037 — LUPO-TEST REAGENT1990-12-17

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