Cleared Traditional

PROTEIN C DEFICIENT PLASMA

K945857 · George King Bio-Medical, Inc. · Hematology
Oct 1995
Decision
340d
Days
Class 2
Risk

About This 510(k) Submission

K945857 is an FDA 510(k) clearance for the PROTEIN C DEFICIENT PLASMA, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by George King Bio-Medical, Inc. (Overland Park, US). The FDA issued a Cleared decision on October 20, 1995, 340 days after receiving the submission on November 14, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K945857 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date October 20, 1995
Days to Decision 340 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GJT — Plasma, Coagulation Factor Deficient
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7290

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