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510(k) K142985

Device
UniCel DxC SYNCHRON System HDL Cholesterol Reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator
Applicant
BECKMAN COULTER, INC.
510(k) number
K142985
Product code
JIT  
Decision
Substantially Equivalent (SESE)
Decision date
2015-02-26
Date received
2014-10-16
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Eimear Carr
Address
250 S. Kreamer Blvd. Brea CA US 92821 92821

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JIT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics2017-05-16
K170938CalSet IGF-1Roche Diagnostics2017-04-26
K170160Abbott ARCHITECT Free T3Abbott Laboratories2017-02-15
K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc.2017-01-13
K163544Lumipulse G ProlactinFujirebio Diagnostics,Inc.2017-01-12
K163521Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc.2017-01-12
K163078DC-UIBC-CALSekisui Diagnostics P.E.I., Inc.2016-12-08
K163053Lumipulse G E2-III CalibratorsFujirebio Diagnostics,Inc.2016-12-01
K162538ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) CalibratorSiemens Healthcare Diagnostics2016-11-17
K160113ST AIA-PACK hsE2 Calibrator SetTosoh Bioscience, Inc.2016-02-17
K153417ST AIA-PACK PROG III Calibrator SetTosoh Bioscience, Inc.2015-12-18
K152526Elecsys Progesterone III CalSetRoche Diagnostics2015-10-02
K151566Abbott ARCHITECT Total T4 CalibratorsAbbott Laboratories2015-07-10
K143342Elecsys T-Uptake CalsetRoche Diagnostics2014-12-19

Legacy Summary#

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FDA Review#

Decision Summary