Cleared Traditional

POSITIVE LUPUS ANTICOAGULANT PLASMA

K945856 · George King Bio-Medical, Inc. · Hematology
Oct 1995
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K945856 is an FDA 510(k) clearance for the POSITIVE LUPUS ANTICOAGULANT PLASMA, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 5, 1995, 325 days after receiving the submission on November 14, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K945856 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date October 05, 1995
Days to Decision 325 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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