FDA.reportPublic FDA data

510(k) K162538

Device
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
510(k) number
K162538
Product code
JIT  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-17
Date received
2016-09-12
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUSAN FERRIN
Address
333 Coney St. East Walpole MA US 02032 02032

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
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
K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26
K143342Elecsys T-Uptake CalsetRoche Diagnostics2014-12-19

Legacy Summary#

summary

FDA Review#

Decision Summary