Cleared Traditional

BIOMERIEUX HEMOLAB FIBRINOMAT

K925494 · Biomerieux Vitek, Inc. · Hematology
May 1993
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K925494 is an FDA 510(k) clearance for the BIOMERIEUX HEMOLAB FIBRINOMAT, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on May 18, 1993, 197 days after receiving the submission on November 2, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K925494 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1992
Decision Date May 18, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

Similar Devices — GIS Test, Fibrinogen

All 12
Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
K143470 · Diazyme Laboratories · Jan 2016
FIBROTEK FIB
K042919 · R2 Diagnostics, Inc. · Nov 2004
K-ASSAY FIBRINOGEN
K993482 · Kamiya Biomedical Co. · Dec 1999
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · Ortho Diagnostic Systems, Inc. · Nov 1996
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
K941001 · Diagnostic Specialties · Aug 1994
IL TEST PT FIBRINOGEN HS
K923921 · Instrumentation Laboratory CO · Oct 1992