Cleared Traditional

STAGO FACTOR V-DEFICIENT PLASMA

K934605 · American Bioproducts Co. · Hematology
Mar 1994
Decision
155d
Days
Class 2
Risk

About This 510(k) Submission

K934605 is an FDA 510(k) clearance for the STAGO FACTOR V-DEFICIENT PLASMA, a Plasma, Coagulation Factor Deficient (Class II — Special Controls, product code GJT), submitted by American Bioproducts Co. (Parsippany, US). The FDA issued a Cleared decision on March 1, 1994, 155 days after receiving the submission on September 27, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7290.

Submission Details

510(k) Number K934605 FDA.gov
FDA Decision Cleared SESE
Date Received September 27, 1993
Decision Date March 01, 1994
Days to Decision 155 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

Similar Devices — GJT Plasma, Coagulation Factor Deficient

All 78
CRYOcheck Factor VIII Deficient Plasma with VWF
K222831 · Precision Biologic, Inc. · Sep 2023
HemosIL Factor XII Deficient Plasma
K180486 · Instrumentation Laboratory CO · Mar 2018
NOFACT VIII
K102851 · R2 Diagnostics, Inc. · Dec 2011
NOFACT IX
K102908 · R2 Diagnostics, Inc. · Dec 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K110237 · Instrumentation Laboratory CO · Jul 2011
HEMOSIL FACTOR II DEFICIENT PLASMA
K050661 · Instrumentation Laboratory CO · May 2005