Cleared Traditional

PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA

K990046 · Pacific Hemostasis · Hematology
Feb 1999
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K990046 is an FDA 510(k) clearance for the PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by Pacific Hemostasis (Huntersville, US). The FDA issued a Cleared decision on February 17, 1999, 41 days after receiving the submission on January 7, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K990046 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 1999
Decision Date February 17, 1999
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

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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