GGC · Class II · 21 CFR 864.5425

FDA Product Code GGC: Control, Plasma, Abnormal

Leading manufacturers include American Bioproducts Co., Analytical Control Systems, Inc. and Medical Diagnostic Technologies, Inc..

40
Total
40
Cleared
121d
Avg days
1977
Since

FDA 510(k) Cleared Control, Plasma, Abnormal Devices (Product Code GGC)

40 devices
1–24 of 40
Cleared Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
K102552
Instrumentation Laboratory CO
Hematology · 210d
Cleared Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
K100103
Helena Laboratories
Hematology · 336d
Cleared Jul 28, 2006
STA - CONTROL LA 1+2
K061803
Diagnostica Stago, Inc.
Hematology · 31d
Cleared Nov 01, 2002
CONTROL PLASMA P
K023312
Dade Behring, Inc.
Hematology · 29d
Cleared Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
K020878
Bio-Rad
Hematology · 28d
Cleared Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
K020109
Sigma Diagnostics, Inc.
Hematology · 26d
Cleared Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
K012422
Kamiya Biomedical Co.
Hematology · 22d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329
Sigma Diagnostics, Inc.
Hematology · 128d
Cleared Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332
Gradipore , Ltd.
Hematology · 135d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130
Pacific Hemostasis
Hematology · 13d
Cleared Dec 01, 1998
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131
Pacific Hemostasis
Hematology · 13d
Cleared May 24, 1996
LA POSITIVE CONTROL PLASMA
K961370
Medical Diagnostic Technologies, Inc.
Hematology · 45d
Cleared Jan 31, 1996
AT-III CONTROL PLASMA KIT
K955040
American Bioproducts Co.
Hematology · 89d
Cleared Nov 06, 1995
CRYO CHECK LUPUS PLASMA
K952623
Precision Biologicals, Inc.
Hematology · 151d
Cleared Oct 30, 1995
CRYO CHECK ABNORMAL REFERENCE CHECK I & II
K952624
Precision Biologicals, Inc.
Hematology · 144d
Cleared Sep 21, 1995
STA-COAG CONTROL [P] PLUS KIT
K952338
American Bioproducts Co.
Hematology · 125d
Cleared Nov 21, 1994
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
K941872
Helena Laboratories
Hematology · 217d
Cleared Mar 22, 1994
BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
K930267
Biomerieux Vitek, Inc.
Hematology · 427d
Cleared Feb 22, 1994
PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
K924401
Behring Diagnostics, Inc.
Hematology · 540d
Cleared Feb 22, 1994
CONTROL PLASMA U
K924402
Behring Diagnostics, Inc.
Hematology · 540d
Cleared May 20, 1993
FACTOR CONTROL [P]
K930959
American Bioproducts Co.
Hematology · 85d
Cleared Apr 27, 1993
COAG-CONTROL
K930923
American Bioproducts Co.
Hematology · 63d
Cleared Dec 01, 1992
CONTROL PLASMA P
K924405
Behring Diagnostics, Inc.
Hematology · 92d
Cleared Jun 09, 1992
AVK CONTROL I & II
K921665
American Bioproducts Co.
Hematology · 63d

About Product Code GGC - Regulatory Context