GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05— 510(k) K993332

Name: FDA 510(k) clearance K993332
Creator: U.S. Food and Drug Administration
Published: 2000-02-16

Substantially Equivalent

Gradipore , Ltd.

FDA 510(k) clearance K993332 for GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05, Substantially Equivalent on 2000-02-16. Applicant: Gradipore , Ltd.. Device class: 2.

Clearance details

Applicant: Gradipore , Ltd.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1999-10-04
Decision date: 2000-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Ryde, AU

Download summary PDF View on FDA.gov ↗

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