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510(k) K033860

Device
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
Applicant
WAKO CHEMICALS, USA, INC.
510(k) number
K033860
Product code
JIT  
Decision
Substantially Equivalent (SESE)
Decision date
2004-04-23
Date received
2003-12-12
Regulation
862.1150
Classification name
Calibrator, Secondary
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
TONYA MALLORY
Address
1600 Bellwood Rd. Richmond VA US 23237 23237

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
K142985UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL CalibratorBeckman Coulter, Inc.2015-02-26

Legacy Summary#

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FDA Review#

Decision Summary