Cleared Traditional

GRADILEIDEN V TEST

K992456 · Gradipore , Ltd. · Hematology
Dec 1999
Decision
151d
Days
Class 2
Risk

About This 510(k) Submission

K992456 is an FDA 510(k) clearance for the GRADILEIDEN V TEST, a Test, Time, Partial Thromboplastin (Class II — Special Controls, product code GGW), submitted by Gradipore , Ltd. (North Ryde, AU). The FDA issued a Cleared decision on December 21, 1999, 151 days after receiving the submission on July 23, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K992456 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1999
Decision Date December 21, 1999
Days to Decision 151 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GGW — Test, Time, Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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