Cleared Traditional

GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05

K993332 · Gradipore , Ltd. · Hematology
Feb 2000
Decision
135d
Days
Class 2
Risk

About This 510(k) Submission

K993332 is an FDA 510(k) clearance for the GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Gradipore , Ltd. (North Ryde, AU). The FDA issued a Cleared decision on February 16, 2000, 135 days after receiving the submission on October 4, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K993332 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1999
Decision Date February 16, 2000
Days to Decision 135 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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