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510(k) K002540

Device
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS
Applicant
BIONOSTICS, INC.
510(k) number
K002540
Product code
JJX  
Decision
Substantially Equivalent (SESE)
Decision date
2000-09-18
Date received
2000-08-16
Regulation
862.1660
Classification name
Single (specified) Analyte Controls (assayed And Unassayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KATHLEEN STORRO
Address
2 Craig Rd. Acton MA US 01720 01720

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JJX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K170678Beta-CrossLaps CalCheck 5Roche Diagnostics2017-04-04
K162173Elecsys CYFRA 21-1 CalCheck 5Roche Diagnostics2017-01-12
K162514Multichem A1cTechnopath Manufacturing2016-10-26
K161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.2016-08-10
K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.2016-06-30
K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.2016-06-30
K161082IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersImmunodiagnostic Systems , Ltd.2016-05-17
K152117Dropper hsCRP High Sensitivity CRP ControlQuantimetrix Corporation2016-04-21
K151742Contour Next Control SolutionBayer Healthcare2015-09-23
K143687ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve MaterialSiemens Healthcare Diagnostics, Inc.2015-07-17
K150955Elecsys Progesterone III Cal Check 5Roche Diagnostics2015-05-01
K150132IMMULITE IGF Control Module, IMMULITE Gastrin Control ModuleSiemens Healthcare Diagnostics2015-04-13
K143324IDS-iSYS CTX-I Calibration VerifiersImmunodiagnostic Systems , Ltd.2015-03-30
K143373IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.2015-02-26
K143636IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc.2015-02-25

Legacy Summary#

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FDA Review#

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