ClearanceBrief
Panels › Hematology › Product code GGC · Class 2

Control, Plasma, Abnormal

Regulation 864.5425

0510(k)s in 12 months (40 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in GGC

Decided510(k)Device and applicantCode
Apr 5, 2011K102552HEMOSIL LA POSITIVE CONTROL
Instrumentation Laboratory CO
GGC
Dec 15, 2010K100103SPECIALTY ASSAYED CONTROL-2
Helena Laboratories
GGC
Mar 16, 2007K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2
R2 Diagnostics, Inc.
GGC
Jul 28, 2006K061803STA - CONTROL LA 1+2
Diagnostica Stago, Inc.
GGC
Nov 3, 2003K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROL
Precision Biologic, CA
GGC
Nov 1, 2002K023312CONTROL PLASMA P
Dade Behring, Inc.
GGC
Apr 15, 2002K020878LYPHOCHEK HEMOSTASIS, MODELS 798, 799
Bio-Rad
GGC
Feb 6, 2002K020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
Sigma Diagnostics, Inc.
GGC
Aug 21, 2001K012422K-ASSAY D-DIMER CONTROLS
Kamiya Biomedical Co.
GGC
Mar 1, 2001K003329SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
Sigma Diagnostics, Inc.
GGC
Feb 16, 2000K993332GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
Gradipore , Ltd., AU
GGC
Dec 1, 1998K984131COAGULATION CONTROL LEVEL 3 (ABNORMAL)
Pacific Hemostasis
GGC
Dec 1, 1998K984130COAGULATION CONTROL LEVEL 2 (ABNORMAL)
Pacific Hemostasis
GGC
May 24, 1996K961370LA POSITIVE CONTROL PLASMA
Medical Diagnostic Technologies, Inc.
GGC
Jan 31, 1996K955040AT-III CONTROL PLASMA KIT
American Bioproducts Co.
GGC
Nov 6, 1995K952623CRYO CHECK LUPUS PLASMA
Precision Biologicals, Inc., CA
GGC
Oct 30, 1995K952624CRYO CHECK ABNORMAL REFERENCE CHECK I & II
Precision Biologicals, Inc., CA
GGC
Oct 5, 1995K945856POSITIVE LUPUS ANTICOAGULANT PLASMA
George King Bio-Medical, Inc.
GGC
Sep 21, 1995K952338STA-COAG CONTROL [P] PLUS KIT
American Bioproducts Co.
GGC
Nov 21, 1994K941872SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
Helena Laboratories
GGC
Mar 22, 1994K930267BIOMERIEUX UNIPLASMATROL NORMAL & ABNORMAL
Biomerieux Vitek, Inc.
GGC
Feb 22, 1994K924402CONTROL PLASMA U
Behring Diagnostics, Inc.
GGC
Feb 22, 1994K924401PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA)
Behring Diagnostics, Inc.
GGC
May 20, 1993K930959FACTOR CONTROL [P]
American Bioproducts Co.
GGC
Apr 27, 1993K930923COAG-CONTROL
American Bioproducts Co.
GGC
Dec 1, 1992K924405CONTROL PLASMA P
Behring Diagnostics, Inc.
GGC
Jun 9, 1992K921665AVK CONTROL I & II
American Bioproducts Co.
GGC
Jun 11, 1991K911885DADE(R) PROTEIN C ABNORMAL CONTRAL
Baxter Healthcare Corp
GGC
Oct 22, 1990K904073COAGULATION REFERENCE PLASMA, ABNORMAL
Medi-Tech, Inc.
GGC
Apr 11, 1990K901233ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
Ortho Diagnostic Systems, Inc.
GGC
Mar 27, 1990K900782HEPARIN CONTROL PLASMA, FOR USE IN APTT
Medical Diagnostic Technologies, Inc.
GGC
Oct 6, 1989K895261ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2)
Medical Diagnostic Technologies, Inc.
GGC
Oct 6, 1989K895260ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
Medical Diagnostic Technologies, Inc.
GGC
Aug 3, 1989K894425ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
Analytical Control Systems, Inc.
GGC
Jul 25, 1989K894338ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL III
Analytical Control Systems, Inc.
GGC
Jul 25, 1989K893971ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
Analytical Control Systems, Inc.
GGC
Jul 25, 1989K893970ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
Analytical Control Systems, Inc.
GGC
May 6, 1988K881510CLP ABNORMAL COAGULATION CONTROL
Creative Laboratory Products, Inc.
GGC
Dec 11, 1987K871420HERPES 1 AND 2 MICROASSAYS
Diamedix Corp.
GGC
Feb 18, 1977K770188HPC TM (HEPARINIZED PLASMA CONTROL)
Bio/Data Corp.
GGC

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