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510(k) K934521

Device
SPQ MALB CONTROL LEVEL II
Applicant
INCSTAR CORP.
510(k) number
K934521
Product code
JJX  
Decision
Substantially Equivalent (SESE)
Decision date
1993-11-26
Date received
1993-09-17
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
MARY ELLEN BEST
Address
1990 Insustrial Blvd. P.O. Box 285 Stillwater MN US 55082 55082

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
K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.2016-06-30
K161526LIAISON CMV 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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