GGN · Class II · 21 CFR 864.5425

FDA Product Code GGN: Plasma, Coagulation Control

Leading manufacturers include Bio-Rad, Instrumentation Laboratory CO and Helena Laboratories.

99
Total
99
Cleared
127d
Avg days
1977
Since
99 devices
49–72 of 99
Cleared Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858
Bio-Rad
Hematology · 37d
Cleared Jun 15, 1998
I-STAT COAGULATION CONTROL SET
K981752
Biopool Intl., Inc.
Hematology · 28d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 29, 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255
Sigma Diagnostics, Inc.
Hematology · 23d
Cleared Apr 27, 1998
THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS
K981178
Cardiovascular Diagnostics, Inc.
Hematology · 26d
Cleared Apr 16, 1998
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982
Avocet Medical, Inc.
Hematology · 30d
Cleared Aug 29, 1997
CRYO CHECK INR VALIDATION SET
K971219
Precision Biologicals, Inc.
Hematology · 149d
Cleared Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
K971222
Precision Biologicals, Inc.
Hematology · 139d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716
American Bioproducts Co.
Hematology · 213d
Cleared Jun 17, 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
K971428
Pacific Hemostasis
Hematology · 61d
Cleared May 29, 1997
TAS PT-NCTEST CONTROLS
K971748
Cardiovascular Diagnostics, Inc.
Hematology · 17d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963
Bio-Rad
Hematology · 71d
Cleared Jul 23, 1996
STA - VWF CONTROL [N]+[P] KIT
K962674
American Bioproducts Co.
Hematology · 14d
Cleared Jun 05, 1996
TAS A PTT TEST CONTROLS
K961189
Cardiovascular Diagnostics, Inc.
Hematology · 71d
Cleared May 30, 1996
BEHRING COAGULATION TIMER
K955278
Behring Diagnostics, Inc.
Hematology · 195d
Cleared May 30, 1996
TAS HMT CONTROLS
K960234
Cardiovascular Diagnostics, Inc.
Hematology · 134d
Cleared Mar 11, 1996
PORCINE FACTOR VIII
K952321
Helena Laboratories
Hematology · 298d
Cleared Jan 03, 1996
CRYO CHECK LOW FIBRINOGEN CONTROL
K951823
Precision Biologicals, Inc.
Hematology · 258d
Cleared Oct 30, 1995
CRYO CHECK NORMAL HUMAN REFERENCE PLASMA
K952622
Precision Biologicals, Inc.
Hematology · 144d
Cleared May 11, 1995
ORTHO ASSAYED REFERENCE PLASMA-NORMAL/ PLASMA-ABNORMAL
K940209
Ortho Diagnostic Systems, Inc.
Hematology · 482d
Cleared Mar 21, 1995
STA SYSTEM CONTROL [N] + [P] KIT
K943518
American Bioproducts Co.
Hematology · 243d
Cleared Mar 15, 1995
ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II
K944691
International Technidyne Corp.
Hematology · 173d
Cleared Sep 14, 1994
SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.)
K941860
Helena Laboratories
Hematology · 152d