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510(k) K032804

Device
CRYOCHECK WEAK LUPUS POSITIVE CONTROL
Applicant
PRECISION BIOLOGIC
510(k) number
K032804
Product code
GGC  
Decision
Substantially Equivalent (SESE)
Decision date
2003-11-03
Date received
2003-09-09
Regulation
864.5425
Classification name
Control, Plasma, Abnormal
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN DUFF
Address
900 Windmill Rd., Suite 100 Dartmouth, N.S. CA B3B 1P7 B3B 1P7

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GGC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory CO2011-04-05
K100103SPECIALTY ASSAYED CONTROL-2Helena Laboratories2010-12-15
K062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.2007-03-16
K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.2006-07-28
K023312CONTROL PLASMA PDade Behring, Inc.2002-11-01
K020878LYPHOCHEK HEMOSTASIS, MODELS 798, 799Bio-Rad2002-04-15
K020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLSigma Diagnostics, Inc.2002-02-06
K012422K-ASSAY D-DIMER CONTROLSKamiya Biomedical Co.2001-08-21
K003329SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217Sigma Diagnostics, Inc.2001-03-01
K993332GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05Gradipore , Ltd.2000-02-16
K984131COAGULATION CONTROL LEVEL 3 (ABNORMAL)Pacific Hemostasis1998-12-01
K984130COAGULATION CONTROL LEVEL 2 (ABNORMAL)Pacific Hemostasis1998-12-01
K961370LA POSITIVE CONTROL PLASMAMedical Diagnostic Technologies, Inc.1996-05-24
K955040AT-III CONTROL PLASMA KITAmerican Bioproducts Co.1996-01-31
K952623CRYO CHECK LUPUS PLASMAPrecision Biologicals, Inc.1995-11-06

Legacy Summary#

summary

FDA Review#

Decision Summary