KQG · Class II · 21 CFR 864.5400

FDA Product Code KQG: Instrument, Coagulation

Leading manufacturers include Volu Sol Medical Industries, Med USA and Pacific Hemostasis.

14
Total
14
Cleared
110d
Avg days
1977
Since

FDA 510(k) Cleared Instrument, Coagulation Devices (Product Code KQG)

14 devices
1–14 of 14
Cleared Aug 16, 2005
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
K050821
Zycare
Hematology · 138d
Cleared Oct 25, 2002
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
K021976
Vital Scientific N.V.
Hematology · 130d
Cleared Sep 03, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130
Pacific Hemostasis
Hematology · 72d
Cleared Jun 21, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
K991321
Pacific Hemostasis
Hematology · 63d
Cleared May 03, 1999
HEMOCHRON RESPONSE
K983475
International Technidyne Corp.
Hematology · 213d
Cleared Nov 08, 1990
ELVI 828 DIGICLOT MULTISCAN
K902614
Logos Scientific, Inc.
Hematology · 148d
Cleared Apr 16, 1990
CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
K900685
Texas Intl. Laboratories, Inc.
Hematology · 63d
Cleared Sep 29, 1986
COAGULATOR (8 CHANNEL)
K862047
Med USA
Hematology · 123d
Cleared Aug 13, 1985
COAGULATOR
K852492
Med USA
Hematology · 62d
Cleared Jun 24, 1985
ELECTRA 800 AUTOMATIC COAGULATION TIMER
K851169
Medical Laboratory Automation Systems, Inc.
Pathology · 94d
Cleared Dec 09, 1982
KOAGULAB 40-A AUTOMATED COAGULATION SYS
K823131
Ortho Diagnostic Systems, Inc.
Hematology · 45d
Cleared Jul 22, 1982
ELVI BICLOT 816
K812906
Volu Sol Medical Industries
Hematology · 276d
Cleared Sep 17, 1979
ELVI 810 CLOTSCANNER
K791587
Volu Sol Medical Industries
Hematology · 31d
Cleared Aug 04, 1977
INCUBATOR, PORTABLE, ACT-STAT
K770914
Thermolyne Corp.
Hematology · 77d

About Product Code KQG - Regulatory Context